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Hiya Kids SPF 40 Mineral Sunscren Zinc Oxide 200 mg/g Paste, 65 g — NDC 85447-0001-01 package photo

Hiya Kids SPF 40 Mineral Sunscren Zinc Oxide 200 mg/g Paste, 65 g

by Hiya Health Products LLC · 65 g in 1 CANISTER (85447-001-01)
NDC 85447-0001-01
🏷️ FDA NDC (as labeled) 85447-001-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Zinc Oxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0212-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0206-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0202-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0207-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0209-2026
Class II · Oct 31, 2025 — cGMP deviations (Blossom Pharmaceuticals) · FDA recall D-0208-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 85447-001-01
Product NDC 85447-001
11-digit billing NDC 85447000101
UNII SOI2LOH54Z
Application # M020
SPL Set ID 33119ec6-2cd8-8978-e063-6394a90afd97
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-01
Route TOPICAL
Dosage form PASTE
Substance ZINC OXIDE
Why two NDCs? The FDA registers this code as 85447-001-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 85447-0001-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerHiya Health Products LLC
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code85447
First marketedMay 2025
Product typeHuman Otc Drug
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

Hiya Kids SPF 40 Mineral Sunscreen is a topical paste containing zinc oxide, an inorganic UV filter. Zinc oxide is commonly used in sunscreen products to reflect and scatter ultraviolet rays away from the skin. This product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established safety and effectiveness rules for the sunscreen category rather than undergoing individual product approval.

Supplement & herbal interactions

Some supplements/herbs that may interact with Zinc oxide (OTC drug) — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Zinc oxide (OTC drug) (3 interactions) — ranked by severity →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • UNII 2ZA36H0S2V
    Beeswax is a natural wax produced by honeybees. In medicines, it works as a coating agent and thickener to control how fast the drug dissolves and improve the product's texture and appearance.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • UNII UDR641JW8W
    A plant-derived oil from jojoba seeds that has been broken down into smaller components. It acts as an emollient and skin-conditioning agent to help soften and smooth the product's texture.
  • UNII MJ76269K9S
    Lemon balm oil is a natural essential oil extracted from the lemon balm plant. In medicines, it typically serves as a flavoring agent and fragrance to improve taste and aroma.
  • UNII V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII 2YWL9J7EE8
    A plant extract from narrow-leaf plantain used as a demulcent and soothing agent in formulations. It may help coat and protect mucous membranes in throat lozenges or cough products.
  • UNII YXH47AOU0F
    A synthetic fatty acid used as a thickener and stabilizer in medicines. It helps create the right texture and prevents separation of ingredients in liquid or semi-solid formulations.
  • UNII 66YXD4DKO9
    A natural oil extracted from almond kernels. It's used in medicines as an emollient and solvent to help dissolve or suspend active ingredients and improve texture in topical and oral formulations.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • UNII GW89575KF9
    Squalane is a lightweight oil derived from plant sources or synthesized. It acts as an emollient and lubricant in formulations, helping ingredients blend smoothly and improving product texture and spreadability.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.

13 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesCera Alba (Beeswax), Extracts of Calendula Officinalis (Marigold) Flower*, Melissa Officinalis (Lemon Balm) Leaf* and Pantago Lanceolata (Plantain) Leaf in Healianthus Annuus (Sunflower) Seed Oil, Jojoba Esters, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sorbitan Olivate, Squalan (Plant-Based) *Certified Organic Ingredients.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer gPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Zinc Oxide 200 mg/g 70000-0334-01 Cardinal 454 g $0.016 — Availability likely —
Nivagen Zinc Oxide 200 mg/g 75834-0170-01 Nivagen 28.4 g $0.107 — Availability likely —
Sheffield Zinc Oxide 200 mg/g 11527-0065-34 Sheffield 1 tube — — FDA listed —
Mineral Body Sunscreen Unscented 200 mg/g 69949-0111-01 Synchronicity 85 g — — FDA listed —
Shunly Zn20 Light Moisturizer 200 mg/g 81381-0205-04 Shunly 113 g — — FDA listed —
Zinc Oxide Pharma 200 mg/g 84387-0001-01 ALLIED 56.6 g — — FDA listed —
Skin Tone Defender 20% Zinc Oxide 200 mg/g 85298-0205-04 Cali 115 g — — FDA listed —
Protect 20 Zinc Oxide Mineral Sunscreen Tinted 200 mg/g 85314-0204-60 Melinda 60 g — — FDA listed —
Protect 20 Zinc Oxide Mineral Sunscreen Non-Tinted 200 mg/g 85314-0205-04 Melinda 113 g — — FDA listed —
Sol Purpose Mineral Sunscreen Tinted 200 mg/g 85317-0204-60 TRU 60 g — — FDA listed —
Sheer Mineral Sunscreen Satin Dewy Finish 200 mg/g 85317-0205-04 TRU 113 g — — FDA listed —
Covered 200 mg/g 85319-0205-15 Potency 1.5 g — — FDA listed —
SPF 40 Broad Spectrum Non-Tinted 200 mg/g 85339-0205-04 Teton 113 g — — FDA listed —
Hydrating Mineral Zinc Oxide SPF 40 200 mg/g 85360-0205-04 Spalina 113 g — — FDA listed —
Glass Skin Sunscreen Tinted 200 mg/g 85428-0204-15 Fleur 1.5 g — — FDA listed —
Hiya Kids SPF 40 Mineral Sunscren 200 mg/gthis 85447-0001-01 Hiya 65 g — — FDA listed —
Non Tinted Mineral Sunscreen 200 mg/g 85460-0205-04 Micro 113 g — — FDA listed —
ProtectME Tinted Mineral SPF 40 20% 200 mg/g 85470-0204-60 PUREFECTION 60 g — — FDA listed —
Skin Filter Glow SPF 200 mg/g 85496-0204-60 MALORIE 60 g — — FDA listed —
Chem-Free Sunscreen Non-Tinted Formula 200 mg/g 85507-0205-04 IT 113 g — — FDA listed —
Simply Zinc Mineral Sunscreen Tinted 200 mg/g 85519-0204-60 SKIN 60 g — — FDA listed —
Gentle Defense Sunscreen 200 mg/g 85533-0205-15 Mint 1.5 g — — FDA listed —
Moisturizing Mineral Sunscreen Tinted 200 mg/g 85558-0204-60 LOTUS 60 g — — FDA listed —
Sacred Aura 200 mg/g 85583-0205-04 IRIA 113 g — — FDA listed —
Mineral Sunscreen 200 mg/g 85645-0205-15 LEILANI 1.5 g — — FDA listed —
Non Tinted Mineral Sunscreen 20Percent Zinc Oxide 200 mg/g 85672-0205-04 JKH 113 g — — FDA listed —
Mineral Sunscreen Tinted Zinc Oxide 200 mg/g 85727-0204-60 KS 60 g — — FDA listed —
Stay Shady Non-Tinted Mineral Sunscreen 200 mg/g 85969-0205-15 AMOIE 1.5 g — — FDA listed —
Critic Aid Skin 200 mg/g 11701-0050-32 Coloplast 170 g — — FDA listed —
CoTZ Kids 200 mg/g 58892-0619-05 Fallien 5 g — — FDA listed —
THERA Calazinc Body Shield 200 mg/g 68599-0205-01 McKesson 144 packets — — FDA listed —
NATURAL MOISTURIZING FACE SUNSCREEN and PRIMER 200 mg/g 69949-0010-01 Synchronicity 50 g — — FDA listed —
5-In-1 Tinted Face Sunscreen - Golden Light 200 mg/g 69949-0053-01 Synchronicity 56.7 g — — FDA listed —
SPF 50 Sunscreen Stick 200 mg/g 79747-0004-01 ELEEO 14 g — — FDA listed —
Daily Moisturizing Glow Sunscreen Cream 200 mg/g 85326-0205-04 Shelley 113 g — — FDA listed —
Tinted Mineral Sunscreen 200 mg/g 85366-0204-60 Gentlehomme 60 g — — FDA listed —
non-tinted face and body mineral sunscreen SPF40 200 mg/g 85370-0205-04 Lisa 113 g — — FDA listed —
The Block 200 mg/g 85444-0204-60 ELITE 60 g — — FDA listed —
Tinted Mineral Sunscreen 200 mg/g 85469-0204-60 JMSE 60 g — — FDA listed —
Tinted Mineral Sunscreen Cream 200 mg/g 85554-0204-60 ESTILO 60 g — — FDA listed —
Sheer Mineral Face And Body Sunscreen Tinted 200 mg/g 85596-0204-60 LAURA 60 g — — FDA listed —
20 Zinc Oxide Tinted Mineral Sunscreen 200 mg/g 85621-0204-60 AGELESS 60 g — — FDA listed —
Tinted Ultra Zinc Face and Body 200 mg/g 85698-0204-60 LIV 60 g — — FDA listed —
Non Tinted Ultra Zinc Face and Body 200 mg/g 85698-0205-04 LIV 113 g — — FDA listed —
Daily Shade Sheer Matte 200 mg/g 85712-0205-04 BLISS 113 g — — FDA listed —
Not YO 80s Zinc Sunscreen 200 mg/g 85752-0205-15 CLEAN 15 g — — FDA listed —
Hint of Tint 200 mg/g 85768-0204-15 L.S. 1.5 g — — FDA listed —
Total Body Block Sunscreen 200 mg/g 85861-0205-15 ADR 1.5 g — — FDA listed —
Solar Shield Face and Body SPF 40 200 mg/g 85944-0205-04 BRIGHT 113 g — — FDA listed —
Tinted Mineral Sunscreen 200 mg/g 87122-0204-60 MADRE 60 g — — FDA listed —
Sun Defense Mineral Sunscreen SPF 30 Face 200 mg/g 54108-0420-01 derma 1 tube — — FDA listed —
CoTZ Flawless Complexion 200 mg/g 58892-0170-50 Fallien 1 tube — — FDA listed —
Proceuticals Private Label by TiZO tinted mineral sunscreen 20% zinc oxide 200 mg/g 58892-0204-50 Fallien 60 g — — FDA listed —
CVS Zinc Oxide 200 mg/g 69842-0065-34 CVS 1 tube — — FDA listed —
Natural Mineral Body Sunscreen 200 mg/g 69949-0100-01 Synchronicity 85 g — — FDA listed —
Healthy Mineral Sunscreen Brightening plus Tint 200 mg/g 85338-0204-60 ZEN 60 g — — FDA listed —
Sun Therapy Sunscreen 200 mg/g 85357-0204-60 Skin 60 g — — FDA listed —
Z Bloc 200 mg/g 85394-0205-04 The 113 g — — FDA listed —
Daily Skin Protection Sunscreen NT 200 mg/g 85479-0205-04 SKINPLUSBYOROYO 113 g — — FDA listed —
Deflectin Tinted Mineral Sunscreen 200 mg/g 85497-0204-60 AEON 60 g — — FDA listed —
Ultra Zinc Physical Defense 200 mg/g 85499-0205-04 ATLANTA 113 g — — FDA listed —
Color Smart Tinted Mineral 200 mg/g 85560-0204-60 MEGAN 60 g — — FDA listed —
Tinted Moisturizing Mineral Sunscreen 200 mg/g 85642-0204-60 EDIT 60 g — — FDA listed —
Mineral Sunscreen Face plus Body 200 mg/g 85727-0205-04 KS 113 g — — FDA listed —
Non-Tinted Mineral Sunscreen Broad Spectrum SPF 40 200 mg/g 85747-0205-04 WECARE 113 g — — FDA listed —
Daily Protect Tinted Mineral Sunscreen 200 mg/g 87199-0204-15 SARAH'S 1.5 g — — FDA listed —
Baby Mineral Sunscreen SPF55 200 mg/g 73418-0100-03 Hello 85.05 g — — FDA listed —
Zinc Oxide SPF 40 Non-Tinted 200 mg/g 85296-0205-04 Skin 113 g — — FDA listed —
Mineral Sunscreen For Face and Body 200 mg/g 85330-0205-04 Skin 113 g — — FDA listed —
Ultra Zinc Mineral Non Tinted 200 mg/g 85357-0205-04 Skin 113 g — — FDA listed —
Mineral Sunscreen Non-Tinted 200 mg/g 85372-0205-04 Glow 113 g — — FDA listed —
face Plus body sunscreen non-tinted 200 mg/g 85425-0205-04 Skin 113 g — — FDA listed —
Tinted Mineral Sunscreen 200 mg/g 85460-0204-60 Micro 60 g — — FDA listed —
Body-Screen 200 mg/g 85496-0205-04 MALORIE 113 g — — FDA listed —
Daytime Moisture SPF40 200 mg/g 85504-0204-60 COLETTE 60 g — — FDA listed —
Chem Free Sunscreen Tinted Formula 200 mg/g 85507-0204-60 IT 60 g — — FDA listed —
Non Tinted Mineral Sunscreen 20Percent Zinc Oxide 200 mg/g 85554-0205-04 ESTILO 113 g — — FDA listed —
Non - Tinted Mineral Sunscreen 200 mg/g 85575-0205-04 NEXTEX 113 g — — FDA listed —
Nourish And Defend 200 mg/g 85584-0204-60 ANASTASIA 60 g — — FDA listed —
20Percent Zinc Oxide Non Tinted 200 mg/g 85585-0205-15 JEFFREY 1.5 g — — FDA listed —
Royal Screen 200 mg/g 85616-0205-15 QUEENIES 15 g — — FDA listed —
Calming Protection SPF40 200 mg/g 85630-0205-04 FRESH 113 g — — FDA listed —
Tinted Sheer Mineral Zinc Sunscreen 200 mg/g 85887-0204-60 SKIN 60 g — — FDA listed —
Daily Protect Mineral Sunscreen 200 mg/g 87199-0205-04 SARAH'S 113 g — — FDA listed —
HEB SPF 50 Kids Purple Mineral Sunscreen Stick Grape Scented 200 mg/g 37808-0039-01 H.E.B. 13.3 g — — FDA listed —
TiZO Ultra Zinc SPF 40 (Tinted) 200 mg/g 58892-0319-01 Fallien 1 tube — — FDA listed —
TiZO ULTRA ZINC Non-Tinted SPF 40 MINERAL SUNSCREEN FOR BODY and FACE With Antioxidants C and E 200 mg/g 58892-0322-30 Fallien 30 g — — FDA listed —
CoTZ Baby 200 mg/g 58892-0618-01 Fallien 1 tube — — FDA listed —
Safeguard SPF 40 200 mg/g 83578-0205-35 Skinsalvation 100 g — — FDA listed —
Glow Shield Spf 200 mg/g 85291-0205-04 ACNE 113 g — — FDA listed —
Zinc Oxide SPF 40 Tinted 200 mg/g 85296-0204-60 Skin 60 g — — FDA listed —
Tinted Zinc Protection 200 mg/g 85339-0204-60 Teton 60 g — — FDA listed —
Prime And Protect Dewy 200 mg/g 85363-0204-60 Kalon 60 g — — FDA listed —
Non Tinted Mineral Sunscreen 200 mg/g 85395-0205-15 SPECKTRA6 1.5 g — — FDA listed —
Canopy Untinted 200 mg/g 85399-0205-04 BORREGO 113 g — — FDA listed —
Ultimate Physical Sunscreen Tinted 200 mg/g 85413-0204-60 HALEM 60 g — — FDA listed —
Solar Eclipse Extreme Sunscreen 200 mg/g 85491-0205-04 ULTRAVIOLET 113 g — — FDA listed —
Non-Tinted Zinc Body And Face SPF40 200 mg/g 85508-0205-15 RSL89 1.5 g — — FDA listed —
Moisturizing Face and Body SPF 200 mg/g 85552-0205-04 SKIN 113 g — — FDA listed —
Non Tinted Mineral Sunscreen 200 mg/g 85589-0205-04 Natur 113 g — — FDA listed —
Sheer Mineral Face And Body Sunscreen Non Tinted 200 mg/g 85596-0205-04 LAURA 113 g — — FDA listed —
Mermaid Glow And Go Non Tinted Mineral Sunscreen 200 mg/g 85647-0205-15 Mermaid 1.5 g — — FDA listed —
Simply Protected Tinted Mineral Sunscreen 200 mg/g 85726-0204-60 Healthy 60 g — — FDA listed —
Non-Tinted 20% Zinc Mineral Sunscreen 200 mg/g 85758-0205-04 BELLA 113 g — — FDA listed —
Eclipse Body Non Tinted 200 mg/g 85890-0205-04 DENISE 113 g — — FDA listed —
Kind Restore Tinted Mineral Sunscreen 200 mg/g 85895-0204-60 POLISH 60 g — — FDA listed —
Premier Zinc 200 mg/g 85971-0205-04 ENSO 113 g — — FDA listed —
TiZO Ultra Zinc SPF 40 (Non-Tinted) 200 mg/g 58892-0317-01 Fallien 1 tube — — FDA listed —
DermacinRx Zinc Oxide Skin Healing 200 mg/g 59088-0563-01 PureTek 4 g — — FDA listed —
Thinkbaby Sunscreen SPF 30 200 mg/g 60781-2003-01 thinkOperations,LLC 18.4 g — — FDA listed —
Tinted Mineral Sunscreen 20% Zinc Oxide 200 mg/g 85306-0204-21 INTEGRATIVE 60 g — — FDA listed —
Florida Babe Active Non-Tinted 20percent Zinc Oxide Mineral Sunscreen 200 mg/g 85337-0205-04 Tichy 113 g — — FDA listed —
Healthy Mineral Sunscreen Face and Body 200 mg/g 85338-0205-04 Zen 113 g — — FDA listed —
MATTE Non Tinted Mineral Sunscreen 200 mg/g 85386-0205-04 Allure 113 g — — FDA listed —
Mineral Sunscreen Zinc Oxide 200 mg/g 85414-0205-04 Hirschman, 113 g — — FDA listed —
Glass Skin Sunscreen Non-Tinted 200 mg/g 85428-0205-04 Fleur 113 g — — FDA listed —
Ultra Sheer Sunscreen 200 mg/g 85462-0205-04 SKINBAR 113 g — — FDA listed —
Gentle Mineral SPF 40 Tinted 200 mg/g 85555-0204-60 ELIZA 60 g — — FDA listed —
Tinted Mineral Sunscreen 200 mg/g 85589-0204-60 Natur 60 g — — FDA listed —
Instant Glow 200 mg/g 85599-0205-15 CLEAN 1.5 g — — FDA listed —
Non Tinted Moisturizing Mineral Sunscreen 200 mg/g 85642-0205-04 EDIT 113 g — — FDA listed —
Face and Body Sunscreen 200 mg/g 85696-0205-04 SCIENCE 113 g — — FDA listed —
Non Tinted Sheer Mineral Zinc Sunscreen 200 mg/g 85887-0205-04 SKIN 113 g — — FDA listed —
Eclipse Face Tinted 200 mg/g 85890-0204-60 DENISE 60 g — — FDA listed —
Mineral Sunscreen 20percent Zinc Oxide 200 mg/g 85987-0205-04 ESTHETICS 113 g — — FDA listed —
Bella Blue Skin Care Tinted Sunscreen 200 mg/g 87099-0204-60 BELLA 60 g — — FDA listed —
Dermatone SPF 50 Sunscreen Stick 200 mg/g 54414-0108-01 Dermatone 14 g — — FDA listed —
Daily Mineral Sunscreen 20% Zinc Oxide 200 mg/g 85306-0205-40 INTEGRATIVE 113 g — — FDA listed —
3-in-1 Daily Vanishing Tinted Sunscreen Cream 200 mg/g 85326-0204-60 Shelley 60 g — — FDA listed —
20Percent Zinc Oxide Sunscreen 200 mg/g 85364-0205-04 Minder 113 g — — FDA listed —
Zinc 20 mineral sunscreen face Plus body 200 mg/g 85367-0205-15 PURE 1.5 g — — FDA listed —
Tinted Mineral Sunscreen 200 mg/g 85375-0204-60 KLOE 60 g — — FDA listed —
Mineral Sunscreen 20percent Zinc Oxide 200 mg/g 85377-0205-04 Mantra 113 g — — FDA listed —
GLOW Tinted Mineral Sunscreen 200 mg/g 85386-0204-60 Allure 60 g — — FDA listed —
The Tinted Mineral Sunscreen 200 mg/g 85412-0204-60 The 60 g — — FDA listed —
Protect ME Non Tinted Mineral SPF 40 200 mg/g 85470-0205-04 PUREFECTION 113 g — — FDA listed —
Non Tinted Mineral Moisturizing Sunscreen 200 mg/g 85490-0205-04 ABOUT 113 g — — FDA listed —
Zinc 20Percent SPF 40 200 mg/g 85531-0205-04 JOHANNA'S 113 g — — FDA listed —
Cotz Sensitive SPF 40 Sunscreen 200 mg/g 58892-0418-01 Fallien 1 tube — — FDA listed —
Thinksport SPF 30 200 mg/g 60781-4487-01 thinkOperations,LLC 1 applicator — — FDA listed —
5-In-1 Tinted Face Sunscreen - Light 200 mg/g 69949-0052-01 Synchronicity 56.7 g — — FDA listed —
SPF 50 Sunscreen Stick 200 mg/g 84061-0129-01 Australian 14 g — — FDA listed —
Florida Babe Active Tinted 20percent Zinc Oxide Mineral Sunscreen 200 mg/g 85337-0204-60 Tichy 60 g — — FDA listed —
tinted face and body mineral sunscreen SPF40 200 mg/g 85370-0204-60 Lisa 60 g — — FDA listed —
Extreme Protection Non Tinted 200 mg/g 85403-0205-15 BIOHEALTH 1.5 g — — FDA listed —
Prevention Body 200 mg/g 85404-0205-15 NY 1.5 g — — FDA listed —
Ultimate Physical Sunscreen 200 mg/g 85413-0205-04 HALEM 113 g — — FDA listed —
Oil Free Anti-Aging 200 mg/g 85466-0204-60 DERMOPERFECTION 60 g — — FDA listed —
20 Zinc Oxide Non-Tinted Mineral Sunscreen 200 mg/g 85621-0205-04 AGELESS 113 g — — FDA listed —
Ultra UV Shade tinted moisturizing mineral SPF 40 200 mg/g 85632-0204-60 Joyce 60 g — — FDA listed —
Ultra Solar Shield non-tinted moisturizing mineral SPF 40 200 mg/g 85632-0205-04 Joyce 113 g — — FDA listed —
Sunshade Mineral Sunscreen 200 mg/g 85730-0205-04 BELLAGENA 113 g — — FDA listed —
Non-Tinted Mineral Sunscreen 200 mg/g 85805-0205-04 OLGA 113 g — — FDA listed —
Bella Blu Skin Care Non Tinted Sunscreen 200 mg/g 87099-0205-15 BELLA 1.5 g — — FDA listed —
Dew Mineral 200 mg/g 87197-0204-60 ADVANCED 60 g — — FDA listed —
HEB SPF 50 Kids Blue Mineral Sunscreen Stick Berry Scented 200 mg/g 37808-0000-01 H.E.B. 13.3 g — — FDA listed —
SPF 50 Sunscreen Stick 200 mg/g 63645-0178-05 OraLabs 14 g — — FDA listed —
Mineral Based Facial Sunscreen 200 mg/g 81679-0205-04 KATHLEEN 113 g — — FDA listed —
Clove Hill acne safe mineral sunscreen SPF 40 200 mg/g 82746-0205-04 Clove 115 g — — FDA listed —
Skin Apeel Pure Protect SPF 40 Broad Spectrum 200 mg/g 83628-0205-40 Skin 113 g — — FDA listed —
Signature Tint SPF 40 200 mg/g 85325-0204-60 ADVANCED 60 g — — FDA listed —
Tinted Mineral Sunscreen Zinc Oxide 200 mg/g 85414-0204-60 Hirschman, 60 g — — FDA listed —
face Plus body sunscreen tinted 200 mg/g 85425-0204-60 Skin 60 g — — FDA listed —
Advanced Mineral Sunscreen 200 mg/g 85452-0205-04 Charisma 113 g — — FDA listed —
Glow Shield 200 mg/g 85516-0204-60 Kristina 60 g — — FDA listed —
20Percent Zinc Total Protection 200 mg/g 85563-0205-04 CLEAR 113 g — — FDA listed —
Ultimate Mineral Protection 200 mg/g 85715-0205-04 MARK 113 g — — FDA listed —
Ageless All Fitz 200 mg/g 85736-0204-60 A.Wall 60 g — — FDA listed —
Yoali SPF 40 200 mg/g 85773-0204-60 YOALI 60 g — — FDA listed —
Aura Defense 200 mg/g 87271-0204-60 Grace 60 g — — FDA listed —
Endit zinc oxide skin protection 200 mg/g 64068-0500-01 EndIt 56.7 g — — FDA listed —
5-In-1 Tinted Face Sunscreen - Fair 200 mg/g 69949-0051-01 Synchronicity 56.7 g — — FDA listed —
5-In-1 Tinted Face Sunscreen - Medium 200 mg/g 69949-0054-01 Synchronicity 56.7 g — — FDA listed —
Tinted Mineral Sunscreen Broad Spectrum SPF 25 200 mg/g 72812-0152-01 Earth 84 g — — FDA listed —
Shunly Zn20 Tinted Light Moisturizer 200 mg/g 81381-0204-60 Shunly 60 g — — FDA listed —
True Tone Non Tinted 200 mg/g 85393-0205-04 That 113 g — — FDA listed —
Body Protect 200 mg/g 85463-0205-04 Noble 113 g — — FDA listed —
Luminous Tinted Moisturizing 200 mg/g 85503-0204-60 SKIN 60 g — — FDA listed —
Proceuticals Private Label by TiZO non-tinted mineral sunscreen 20% zinc oxide 200 mg/g 58892-0205-04 Fallien 113 g — — FDA listed —
Baby Mineral Sunscreen Probiotics SPF55 200 mg/g 73418-0101-03 Hello 85.05 g — — FDA listed —
Mineral Sunscreen SPF 50 200 mg/g 73418-0102-05 Hello 141.75 g — — FDA listed —
Medline 200 mg/g 53329-0255-05 Medline 170 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Hiya Kids SPF 40 Mineral Sunscren (this brand).

Top reported reactions

Macular Degeneration460
Pyrexia306
Nausea290
Pain282
Malaise261
Weight Decreased236
Therapeutic Product Effect Incomplete214

Reporter sex

1,941 reports

Serious outcomes

Hospitalization988
Death204
Life-threatening116
Disabling32
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 272 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85447-0001-01 You're viewing this 65 g in 1 CANISTER (85447-001-01) 2025-05-01 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 85447-001-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 85447-0001-01, written without dashes as 85447000101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 85447-0001-01, the first segment (85447) is the labeler code FDA assigned to Hiya Health Products LLC; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Hiya Health Products LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Hiya Health Products LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 3 words ▾

Helps prevent sunburn.

⏱️ Dosage and Administration 95 words ▾

Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours. For children under 6 months of age: ask a doctor.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am - 2 pm.

Wear long-sleeved shirts, pants, hats, and sunglasses.

⚠️ Warnings 34 words ▾

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove.

🧪 Active Ingredient 3 words ▾

Zinc Oxide 20%

🧪 Inactive Ingredients 48 words ▾

Cera Alba (Beeswax), Extracts of Calendula Officinalis (Marigold) Flower*, Melissa Officinalis (Lemon Balm) Leaf* and Pantago Lanceolata (Plantain) Leaf in Healianthus Annuus (Sunflower) Seed Oil, Jojoba Esters, Mica, Mixed Tocopherols (Vitamin E), Polyhydroxystearic Acid, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sorbitan Olivate, Squalan (Plant-Based) *Certified Organic Ingredients.

🎯 Purpose 1 words ▾

Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85446-0045-02 · FEELFREE 85448-0001-01 · Jiangsu →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.