Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen 7.5 g/100g; 10 g/100g Lotion, 30 g — NDC 59735-0140-01 package photo

Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen 7.5 g/100g; 10 g/100g Lotion, 30 g

by Mana Products · 30 g in 1 TUBE (59735-140-01)
NDC 59735-0140-01
🏷️ FDA NDC (as labeled) 59735-140-01 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 →

🆔 Identity & classification

FDA NDC (as labeled) 59735-140-01
Product NDC 59735-140
11-digit billing NDC 59735014001
UNII 4Y5P7MUD51, 15FIX9V2JP
UPC 0050428274415
Application # part352
SPL Set ID d0e00d97-dbf4-46af-aeda-bdfd6f49b5ab
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH FINAL
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-09-08
Route TOPICAL
Dosage form LOTION
Substance OCTINOXATE; TITANIUM DIOXIDE
Why two NDCs? The FDA registers this code as 59735-140-01 — 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 → 59735-0140-01. 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

LabelerMana Products
FDA applicationpart352 (OTC MONOGRAPH FINAL)
Labeler code59735
First marketedSep 2016
Product typeHuman Otc Drug
Portfolio4 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 lotion marketed as a cosmetic and over-the-counter sunscreen product under FDA's OTC monograph rules. It contains two active sunscreen ingredients: octinoxate and titanium dioxide, which are typically used as ultraviolet light filters to help protect skin from sun damage. The product is formulated as a tinted moisturizing cream (BB cream) and is labeled to provide broad spectrum sun protection with an SPF of 30.

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 0J9G6W44DV
    A plant extract from the bark of the silk tree, used as a natural binding and thickening agent in some formulations to help hold ingredients together and add consistency to the medicine.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII DQG8119XKJ
    A waxy compound derived from behenic acid and benzoic acid. It serves as a lubricant and emollient in topical formulations, helping the medicine spread smoothly and improving texture.
  • UNII 3SCV180C9W
    Betaine is a naturally occurring organic compound found in plants and animals. In medicines, it acts as an osmoprotectant and stabilizer, helping maintain the product's moisture balance and preserve its chemical stability during storage.
  • 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 GC844VRD7E
    A synthetic fatty acid ester derived from plant oils and lactic acid. It acts as an emulsifier and solvent to help mix oil and water-based ingredients and improve how the medicine dissolves or spreads in the body.
  • 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 ZF29F7IK5I
    A blend of plant-derived fats that helps dissolve and deliver active ingredients. It acts as a solvent and carrier in liquid or soft capsule formulations, improving how the body absorbs certain drugs.
  • 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 SDQ136WIM5
    A plant-derived oil extracted from safflower flowers, used as an emollient and lubricant in medications. It helps soften formulations and can improve how the product spreads or coats on skin or mucous membranes.
  • UNII 3J2P07GVB6
    Cellulose acetate is a plant-derived polymer made by chemically modifying cellulose fibers. In medications, it serves as a film-coating material for tablets and capsules to protect the drug, control release, and improve appearance.
  • UNII C04977SRJ5
    Ceramide NG is a naturally occurring lipid compound that helps form protective barriers in skin and cosmetic formulations. It functions as an emollient and skin-conditioning agent, helping products retain moisture and maintain smooth texture.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII 6V475AX06U
    A chelating agent derived from ethylenediaminetetraacetic acid (EDTA) combined with copper. It binds metals in formulations to prevent discoloration and degradation, helping preserve the medicine's stability and appearance.
  • UNII N76ISC4ZZO
    Ethoxydiglycol behenate is a synthetic compound used as an emulsifier and solubilizer in medicines. It helps blend oil and water-based ingredients together and improves how the drug dissolves in the body.
  • 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 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 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • UNII KEH0A3F75J
    Hexylene glycol is a clear liquid alcohol used as a solvent and preservative in medicines. It helps dissolve other ingredients and keeps the product stable during storage.
  • UNII H1109Z9J4N
    A natural emulsifier derived from soybean oil. It helps mix oil and water-based ingredients together, ensuring even distribution of active ingredients throughout the medicine.
  • UNII X33R8U0062
    Isostearic acid is a fatty acid derived from vegetable oils. It acts as an emulsifier and lubricant in medicines, helping blend ingredients together and reducing friction during tablet or capsule manufacturing.
  • UNII 930626MWDL
    A plant extract from goji berries used as a natural coloring agent and flavor enhancer in medicines. It may add color and taste while serving as a source of beneficial plant compounds in the formulation.
  • UNII K3Z4F929H6
    Lysine is an amino acid that serves as a buffer and pH regulator in medications. It helps maintain the medicine's stability and proper acidity level during storage and use.
  • UNII 02F3473H9O
    A mineral salt used in medications as a source of magnesium. It helps bind ingredients together, improve texture, and maintain the product's stability during storage.
  • UNII AS46JK7Q6I
    A synthetic polymer used as a film-forming agent and binder in medications. It helps create protective coatings on tablets or capsules and improves how ingredients stick together in solid dosage forms.
  • UNII X8725R883T
    A synthetic oily liquid derived from branched carboxylic acids, used as an emollient and skin-conditioning agent in topical formulations. It helps soften and smooth the product's texture while improving how it spreads on skin.
  • UNII HO4ZT5S86C
    A synthetic peptide derived from amino acids, used as a skin-conditioning agent and emollient in topical formulations to help soften and smooth the skin surface.
  • 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 K9X3A45CI6
    A plant-derived compound mixed with polyethylene glycol, a water-soluble polymer. It acts as an emulsifier and solubilizer to help keep oil and water-based ingredients mixed together in the medicine.
  • UNII 788QAG3W8A
    A synthetic polymer that combines polyethylene glycol, glycidyl ether, and sodium hyaluronate. It acts as a thickener and film-former in topical products, helping maintain texture and improve how the medicine spreads on skin.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • 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 W4TKW9D5GG
    Physalis angulata is a plant extract used as a natural flavoring or coloring agent in some medicines. It may also serve as a botanical ingredient to support the product's formulation.
  • UNII 8LVI07A72W
    Phytantriol is a branched-chain alcohol derived from plant sources. It acts as an emulsifier and solvent in formulations, helping mix oil and water-based ingredients together.
  • UNII 46P231IQV8
    A synthetic emulsifier derived from glycerin and fatty acids. It helps blend oil and water-based ingredients together in cosmetic and pharmaceutical formulations to create stable, uniform products.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 660YQ98I10
    Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 8W46YN971G
    Sodium dehydroacetate is a salt derived from dehydroacetic acid, a compound used as a preservative. It helps prevent mold, bacteria, and yeast growth in medicines, extending shelf life and maintaining product safety.
  • 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 V56DFE46J5
    Steareth-2 is a synthetic emulsifier made from stearic acid and ethylene oxide. It helps mix oil and water-based ingredients together in the formulation and may improve how the medicine spreads or dissolves.
  • UNII 53J3F32P58
    A synthetic detergent derived from stearic acid, a fatty substance. It helps dissolve or distribute oil-based ingredients evenly throughout the medicine, acting as an emulsifier and solubilizer in tablets and capsules.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII 9LBV3F07AZ
    A synthetic, oil-soluble form of vitamin C used as an antioxidant to prevent degradation of the medicine and maintain its stability during storage.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling 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 8OC9U7TQZ0
    Tribehenin is a waxy, plant-derived substance that acts as a lubricant and glidant in tablets and capsules. It helps the medicine flow smoothly during manufacturing and prevents sticking during production and packaging.
  • 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 7K3W1BIU6K
    A synthetic oil derived from glycerin and hexanoic acid. It acts as an emollient and lubricant in topical formulations to soften skin and improve product spreadability.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII 86Q357L16B
    Zinc chloride is a mineral salt used as a buffer and pH regulator in medications. It helps maintain the chemical stability and proper acidity level of the drug formulation.

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

The official label also statesWATER (AQUA), CAPRYLIC./CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE, OCTYLDODECYL NEOPENTANOATE, Cl2-15 ALKYL BENZOATE, BUffiENE GLYCOL, BEHENYL ALCOHOL, STEARETH-2, STEARETH-21, STEARIC ACID, TRIETHYLHEXANOIN, ISOSTEARIC ACID, POLYGLYCERYL-3 DIISOSTEARATE, CETYL ALCOHOL, TOCOPHEROL, TOCOPHERYL ACETATE, TETRAHEXYLOECYL ASCORBATE, ALBIZIA JULIBRISSIN BARK EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, GLYCYRRHIZA GLABRA ROOT EXTRACT, PHYSALIS ANGULATA EXTRACT, ACHRAS SAPOTA (MAMEY) EXTRACT, LYCIUM BARBARUM FRUIT EXTRACT, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, TREMELLA FUCIFORMIS SPOROCARP EXTRACT, HYDROGENATED LECITH IN, PANTHENOL, SQUALANE, GLYCERIN, CERAMIDE NG, PEG-10 PHYTOSTEROL, PALMITOYL HEXAPEPTIDE-12, PALMITOYL HEXAPEPTIDE-14, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, ZINC CHLORIDE, LYSINE, PHYTDSTERYUISOSTEARYL/CETYUSTEARYUBEHENYL DIMER DILINOLEATE, SODIUM HYALURONATE CROSSPOLYMER, DIMETHYLACRYLAMIDE/ACRYLIC ACID/POLYSTYRENE ETHYL METHACRYLATE COPOLYMER, POLYSORBATE 80, STEARYL ALCOHOL, PHYTANTRIOL, XANTHAN GUM, SIMETHICONE, CELLULOSE GUM, ALUMINA, PENTYLENE GLYCOL, ETHOXYDIGLYCOL, TRIETHOXYCAPRYLYLSILANE, TRIBEHEN IN, BETAINE, HEXYLENE GLYCOL, DISODIUM EDTA, CITRIC ACID, SODIUM BENZOATE, POTASSIUM SORBATE, SODIUM DEHYDROACETATE, ETHYLHEXYLGLYCERIN, CAPRYLYL GLYCOL, PHENOXYETHANOL, FRAGRANCE (PARFUM). MAY CONTAIN C+/·l: IRON OXIDES (Cl 77492), MICA, IRON OXIDES (Cl 77491), TITANIUM DIOXIDE (Cl 77891), IRON OXIDES (Cl 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 DailyMedingredient 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
Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen 7.5 g/100g; 10 g/100gthis 59735-0140-01 Mana 30 g FDA listed
Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 Sunscreen 7.5 g/100g; 10 g/100g 69842-0801-01 CVS 30 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

🏛️
2016
On the market since
Sep 2016
📍
2026
Currently FDA-listed
10 years 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
59735-0140-01 You're viewing this 30 g in 1 TUBE (59735-140-01) 2016-09-08 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 Final". 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 59735-140-01, 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: 59735-0140-01, written without dashes as 59735014001. 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 59735-0140-01, the first segment (59735) is the labeler code FDA assigned to Mana Products; the middle segment (0140) 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 Mana Products. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Mana Products 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 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 89 words

Directions Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use water resistant sunscreen if swimming or sweathing Sun Protection Measures: Spending time in the sun decreases risk of skin cancer and early again. To decrease this risk, regulaory 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 10:00 am - 2:00 pm. Wear long sleeved shirts, pants, hats and sunglasses.

Children under 6 months: ask a doctor

⚠️ Warnings and Cautions 54 words

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

🧪 Active Ingredient 7 words

Active Ingredients Octinoxate 7.50% Titanium Dioxide 10%

🧪 Inactive Ingredients 153 words

Inactive Ingredients WATER (AQUA), CAPRYLIC./CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE, OCTYLDODECYL NEOPENTANOATE, Cl2-15 ALKYL BENZOATE, BUffiENE GLYCOL, BEHENYL ALCOHOL, STEARETH-2, STEARETH-21, STEARIC ACID, TRIETHYLHEXANOIN, ISOSTEARIC ACID, POLYGLYCERYL-3 DIISOSTEARATE, CETYL ALCOHOL, TOCOPHEROL, TOCOPHERYL ACETATE, TETRAHEXYLOECYL ASCORBATE, ALBIZIA JULIBRISSIN BARK EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, GLYCYRRHIZA GLABRA ROOT EXTRACT, PHYSALIS ANGULATA EXTRACT, ACHRAS SAPOTA (MAMEY) EXTRACT, LYCIUM BARBARUM FRUIT EXTRACT, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, TREMELLA FUCIFORMIS SPOROCARP EXTRACT, HYDROGENATED LECITH IN, PANTHENOL, SQUALANE, GLYCERIN, CERAMIDE NG, PEG-10 PHYTOSTEROL, PALMITOYL HEXAPEPTIDE-12, PALMITOYL HEXAPEPTIDE-14, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, ZINC CHLORIDE, LYSINE, PHYTDSTERYUISOSTEARYL/CETYUSTEARYUBEHENYL DIMER DILINOLEATE, SODIUM HYALURONATE CROSSPOLYMER, DIMETHYLACRYLAMIDE/ACRYLIC ACID/POLYSTYRENE ETHYL METHACRYLATE COPOLYMER, POLYSORBATE 80, STEARYL ALCOHOL, PHYTANTRIOL, XANTHAN GUM, SIMETHICONE, CELLULOSE GUM, ALUMINA, PENTYLENE GLYCOL, ETHOXYDIGLYCOL, TRIETHOXYCAPRYLYLSILANE, TRIBEHEN IN, BETAINE, HEXYLENE GLYCOL, DISODIUM EDTA, CITRIC ACID, SODIUM BENZOATE, POTASSIUM SORBATE, SODIUM DEHYDROACETATE, ETHYLHEXYLGLYCERIN, CAPRYLYL GLYCOL, PHENOXYETHANOL, FRAGRANCE (PARFUM).

MAY CONTAIN C+/·l: IRON OXIDES (Cl 77492), MICA, IRON OXIDES (Cl 77491), TITANIUM DIOXIDE (Cl 77891), IRON OXIDES (Cl 77499).

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.