Label: HYDRATING PROTECTION SUNSCREEN SPF 50 CVS- avobenzone 3.00% homosalate 10.00% octisalate 5.00% octocrylene 6.00% oxybenzone 5.00% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 69842-051-03 - Packager: CVS
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 26, 2017
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 3%...................................................................Sunscreen
Homosalate 10%..................................................................Sunscreen
Octisalate 5%.......................................................................Sunscreen
Octocrylene 6%.............................................................. ....Sunscreen
Oxybenzone 5%............................................................ ......Sunscreen - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
• apply liberally 15 minutes before sun exposure
• reapply:• after 80 minutes of swimming or sweating
• immediately after towel drying• at least every 2 hours
• 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 of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor -
INACTIVE INGREDIENT
Inactive ingredients
Water, Hydrated Silica, Adipic Acid/Diglycol
Crosspolymer, Polyester-8, Acrylates/C12-22 Alkyl Methacrylate Copolymer,
Avena Sativa (Oat) Kernel Extract, Hydrolyzed Oat Protein, Potassium
Palmitoyl Hydrolyzed Oat Protein, Avena Sativa (Oat)
Kernel Flour, Codium Tomentosum Extract, Artemia
Extract, Bisabolol, BHT, Cyclopentasiloxane,
Styrene/Acrylates Copolymer, Acrylates/Dimethicone
Copolymer, Glycerin, Beeswax, Acrylates/C10-30
Alkyl Acrylate Crosspolymer, Triethanolamine,
Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol,
Ethylhexylglycerin, Disodium EDTA, Butylene Glycol,
Dipotassium Glycyrrhizate, Fragrance - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDRATING PROTECTION SUNSCREEN SPF 50 CVS
avobenzone 3.00% homosalate 10.00% octisalate 5.00% octocrylene 6.00% oxybenzone 5.00% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-051 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 6 g in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) HYDRATED SILICA (UNII: Y6O7T4G8P9) ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) OAT (UNII: Z6J799EAJK) CODIUM TOMENTOSUM (UNII: B8B45BRU87) LEVOMENOL (UNII: 24WE03BX2T) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) YELLOW WAX (UNII: 2ZA36H0S2V) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-051-03 88 mL in 1 TUBE; Type 0: Not a Combination Product 02/16/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/16/2017 Labeler - CVS (062312574) Registrant - Product Quest Mfg. (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg. 927768135 manufacture(69842-051)
