Label: HYDRATING PROTECTION SUNSCREEN CVS- avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% oxybenzone 6.0% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 69842-054-03 - Packager: CVS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 12, 2017
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 3%...................................................................Sunscreen
Homosalate 15%..................................................................Sunscreen
Octisalate 5%.......................................................................Sunscreen
Octocrylene 10%..................................................................Sunscreen
Oxybenzone 6%..................................................... .............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
Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer,
Acrylates/Dimethicone Copolymer, Adipic Acid/Diglycol Crosspolymer, Avena
Sativa (Oat) Kernel Extract, Avena Sativa (Oat) Kernel
Flour, Beeswax, BHT, Bisabolol, Cyclopentasiloxane,
Dipotassium Glycyrrhizate, Disodium EDTA,
Ethylhexylglycerin, Fragrance, Glycerin, Glyceryl
Stearate, Hydrated Silica, Hydrolyzed Oat Protein,
PEG-100 Stearate, Phenoxyethanol, Polyester-8,
Potassium Palmitoyl Hydrolyzed Oat Protein,
Styrene/Acrylates Copolymer,Triethanolamine, Water - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HYDRATING PROTECTION SUNSCREEN CVS
avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% oxybenzone 6.0% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-054 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 15 g in 100 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 10 g in 100 mL Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone 6 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19) YELLOW WAX (UNII: 2ZA36H0S2V) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) LEVOMENOL (UNII: 24WE03BX2T) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) EDETATE DISODIUM (UNII: 7FLD91C86K) Ethylhexylglycerin (UNII: 147D247K3P) Glycerin (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Hydrated Silica (UNII: Y6O7T4G8P9) PEG-100 Stearate (UNII: YD01N1999R) Phenoxyethanol (UNII: HIE492ZZ3T) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) TROLAMINE (UNII: 9O3K93S3TK) WATER (UNII: 059QF0KO0R) OAT (UNII: Z6J799EAJK) OATMEAL (UNII: 8PI54V663Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-054-03 88 mL in 1 PACKAGE; 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(69842-054)