Home › NDC Lookup › Ingredients › Homosalate, Octisalate, Octocrylene, Zin... › 76354-0168-01
e.l.f. Hydrating Camo CC Cream SPF30 Rich 650 C HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g Cream — NDC 76354-0168-01 package photo

e.l.f. Hydrating Camo CC Cream SPF30 Rich 650 C HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g Cream

by e.l.f. Cosmetics, Inc. · 1 TUBE in 1 CARTON (76354-168-01) / 30 g in 1 TUBE
NDC 76354-0168-01
🏷️ FDA NDC (as labeled) 76354-168-01 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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

🆔 Identity & classification

FDA NDC (as labeled) 76354-168-01
Product NDC 76354-168
11-digit billing NDC 76354016801
UNII 4X49Y0596W, SOI2LOH54Z, V06SV4M95S, 5A68WGF6WM
Application # M020
SPL Set ID 3fa7ef54-2c4d-9883-e063-6294a90a8d88
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-09-17
Route TOPICAL
Dosage form CREAM
Substance ZINC OXIDE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Why two NDCs? The FDA registers this code as 76354-168-01 — 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 → 76354-0168-01. 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

Labelere.l.f. Cosmetics, Inc.
FDA applicationM020 (OTC MONOGRAPH DRUG)
Labeler code76354
First marketedSep 2025
Product typeHuman Otc Drug
Portfolio158 products on file
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?

This is a topical cream sold as an over-the-counter sunscreen product under the FDA's established monograph for sunscreens. It contains four active ingredients that function as UV filters: homosalate, octisalate, and octocrylene are organic compounds that absorb ultraviolet radiation, while zinc oxide is an inorganic mineral that reflects and scatters UV light. The product also includes other ingredients typical of a cosmetic cream base to hydrate and provide color coverage to the skin.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII 5QB0T2IUN0
    Aluminum hydroxide is a white powder mineral compound used as an antacid ingredient in some formulations. It works as a buffer and pH regulator to help neutralize stomach acid in the medicine.
  • UNII QN83US2B0N
    Ascorbyl palmitate is a fat-soluble form of vitamin C used as an antioxidant in medicines. It prevents oils and fats in the product from breaking down and becoming less stable over time.
  • UNII 01YAE03M7J
    Beta carotene is a naturally occurring orange pigment found in plants. In medicines, it serves as a colorant to make tablets or capsules appear orange or yellow.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 75D21FL1PI
    A synthetic liquid derived from butylene glycol and fatty acids. It acts as an emollient and solvent to help dissolve or suspend active ingredients, improving texture and absorption in topical or oral formulations.
  • UNII 2EH13UN8D3
    A synthetic compound used as a solvent and penetration enhancer in topical formulations. It helps dissolve active ingredients and allows them to penetrate the skin more effectively.
  • UNII 331KBJ17RK
    Canola oil is a plant-based oil derived from rapeseed. It's used in medicines as a solvent and carrier to help dissolve or suspend active ingredients, and may improve how the body absorbs certain medications.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII L56Z1JK48B
    A vegetable-derived ingredient used primarily as a natural colorant and flavoring agent in medicines. It provides orange-yellow color and mild taste to tablets, capsules, or liquids.
  • UNII 595AO13F11
    Carrot seed oil is a plant-based oil extracted from carrot seeds. It's used in medicines as a flavor and fragrance component, and may help distribute active ingredients evenly throughout the formulation.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII X687XDK09L
    A clay mineral processed to carry positive charges, used as a thickener and suspending agent in liquid medicines. It helps keep solid particles evenly distributed throughout the product.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII Y6O7T4G8P9
    Hydrated silica is a fine powder form of silicon dioxide with absorbed water. It works as an anti-caking agent and absorbent in medicines, helping powders stay free-flowing and preventing clumping.
  • UNII DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII 8JC99XGU4W
    Soluble fish skin collagen is a protein derived from fish skin that acts as a binder and thickening agent in medicines. It helps hold ingredients together and gives the product the right texture or consistency.
  • UNII 25X51I8RD4
    Niacinamide is a form of vitamin B3, a water-soluble nutrient. In medicines, it may be added as a nutritional supplement or to support skin health, though its primary role here is as an active ingredient rather than a traditional inactive filler.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 820DPX33S7
    A synthetic emulsifier derived from glycerin and fatty acids. It helps mix oil and water-based ingredients together and keeps them evenly blended throughout the product.
  • 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.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII B8WCK70T7I
    Trehalose is a natural sugar made from two glucose molecules linked together. It's used in medicines as a filler to add bulk, a sweetener for taste, and a stabilizer to help keep active ingredients effective during storage.
  • UNII 4938BNS0GU
    A fungal extract from tremella fuciformis, a jelly-like mushroom. It acts as a thickener, emulsifier, and skin-conditioning agent in topical formulations to improve texture and moisture retention.
  • UNII LDC331P08E
    A silicone-based compound that acts as a glidant and flow agent in solid medications. It reduces friction between powder particles, helping the medicine flow smoothly during manufacturing and tablet compression.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesWater (Aqua) Dimethicone, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Butyloctyl Salicylate, Butylene Glycol Dicaprylate/ Dicaprate, Panthenol, Synthetic Fluorphlogopite, Polyglyceryl-4 Isostearate, Magnesium Sulfate, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Trehalose, Phenoxyethanol, Hydrated Silica, Disteardimonium Hectorite, Triethoxycaprylylsilane, Hydrogen Dimethicone, Aluminum Hydroxide, Triethyl Citrate, Ethylhexylglycerin, Caprylyl Glycol, Disodium EDTA, Tin Oxide, Tocopheryl Acetate, Tremella Fuciformis Extract, Sodium Hyaluronate, Niacinamide, Ascorbyl Palmitate, Canola Oil, Glycerin, Daucus Carota Sativa (Carrot) Seed Oil, 1,2-Hexanediol, Daucus Carota Sativa (Carrot) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Beta-Carotene, Soluble Collagen May Contain: Titanium Dioxide (CI 77891), Yellow Iron Oxide (CI 77492), Red Iron Oxide (CI 77491), Black Iron Oxide (CI 77499)

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
e.l.f. Hydrating Camo CC Cream SPF30 Fair 150 C 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0144-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Tan 425 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0157-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Camo CC Cream SPF 30 Tan 450 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0192-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Camo CC Cream SPF 30 Fair 120 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0180-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Light 240 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0147-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Medium 375 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0154-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Tan 460 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0159-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Deep 560 C 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0164-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Camo CC Cream SPF 30 Medium 310 C 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0186-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Camo CC Cream SPF 30 Tan 514 C 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0190-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Tan 450 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0158-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Deep 510 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0161-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Deep 530 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0162-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Rich 660 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0169-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Camo CC Cream SPF 30 Fair 150 C 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0182-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Camo CC Cream SPF 30 Medium 375 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0189-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Camo CC Cream SPF 30 Tan 425 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0191-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Fair 100 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0140-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Tan 400 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0155-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Fair 120 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0141-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Light 205 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0145-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Medium 310 C 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0150-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Deep 540 C 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0163-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Camo CC Cream SPF 30 Light 240 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0184-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Camo CC Cream SPF 30 Medium 330 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0187-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Light 280 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0149-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Medium 330 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0151-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Medium 355 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0152-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Rich 610 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0165-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Camo CC Cream SPF 30 Fair 140 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0181-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Camo CC Cream SPF 30 Light 280 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0185-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Camo CC Cream SPF 30 Medium 355 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0188-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Light 250 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0148-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Deep 500 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0160-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Rich 650 C 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/gthis 76354-0168-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Medium 370 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0153-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Rich 620 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0166-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Camo CC Cream SPF 30 Light 210 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0183-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Camo CC Cream SPF 30 Deep 500 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0193-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Fair 140 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0143-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Light 210 N 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0146-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Tan 415 C 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0156-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Hydrating Camo CC Cream SPF30 Rich 640 W 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0167-01 e.l.f. 1 tube — — FDA listed —
e.l.f. Camo CC Cream SPF 30 Deep 510 C 63 mg/g; 50 mg/g; 45 mg/g; 30 mg/g 76354-0200-01 e.l.f. 1 tube — — 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
Sep 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
76354-0168-01 You're viewing this 1 TUBE in 1 CARTON (76354-168-01) / 30 g in 1 TUBE 2025-09-18 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 76354-168-01, 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: 76354-0168-01, written without dashes as 76354016801. 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 76354-0168-01, the first segment (76354) is the labeler code FDA assigned to e.l.f. Cosmetics, Inc.; the middle segment (0168) 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 e.l.f. Cosmetics, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
e.l.f. Cosmetics, Inc. 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 29 words ▾

Use Helps prevent sunburn If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

⏱️ Dosage and Administration 88 words ▾

Directions Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use water resistant sunscreen if swimming or sweating.

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 10 a.m.-2 p.m. wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: ask a doctor.

Sun Protection Measures:

⚠️ Warnings 54 words ▾

Warning For external use ony. Do not use on damaged or broken skin. When usingt this product: keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if: rash occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 17 words ▾

Active ingredients Homosalate - 5% Octisalate - 4.5% Octocrylene - 3% Zinc Oxide - 6.3% Purpose Sunscreen

🧪 Inactive Ingredients 100 words ▾

Inactive Ingredients Water (Aqua) Dimethicone, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Butyloctyl Salicylate, Butylene Glycol Dicaprylate/ Dicaprate, Panthenol, Synthetic Fluorphlogopite, Polyglyceryl-4 Isostearate, Magnesium Sulfate, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Trehalose, Phenoxyethanol, Hydrated Silica, Disteardimonium Hectorite, Triethoxycaprylylsilane, Hydrogen Dimethicone, Aluminum Hydroxide, Triethyl Citrate, Ethylhexylglycerin, Caprylyl Glycol, Disodium EDTA, Tin Oxide, Tocopheryl Acetate, Tremella Fuciformis Extract, Sodium Hyaluronate, Niacinamide, Ascorbyl Palmitate, Canola Oil, Glycerin, Daucus Carota Sativa (Carrot) Seed Oil, 1,2-Hexanediol, Daucus Carota Sativa (Carrot) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Beta-Carotene, Soluble Collagen May Contain: Titanium Dioxide (CI 77891), Yellow Iron Oxide (CI 77492), Red Iron Oxide (CI 77491), Black Iron Oxide (CI 77499)

🎯 Purpose 2 words ▾

Purpose Sunscreen

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 76354-0167-01 · e.l.f. 76354-0169-01 · e.l.f. →
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.