HYDRATING PROTECTION SUNSCREEN SPF 30 CVS- avobenzone 3.00% homosalate 8.00% octisalate 4.00% octocrylene 4.00% oxybenzone 5.00% lotion 
CVS

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.

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Drug Facts

Active ingredients                                                             Purpose
Avobenzone 3%..................................................................Sunscreen
Homosalate 8%..................................................................Sunscreen
Octisalate 4%.....................................................................Sunscreen
Octocrylene 4%..................................................................Sunscreen
Oxybenzone 5%.................................................................Sunscreen

Uses • helps prevent sunburn

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 doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

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 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, Codium Tomentosum Extract, Avena Sativa
(Oat) Kernel Flour, Artemia Extract, Bisabolol,
Cyclopentasiloxane, Acrylates/Dimethicone
Copolymer, Styrene/Acrylates Copolymer, Glycerin,
Beeswax, Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Triethanolamine, Glyceryl Stearate,
PEG-100 Stearate, BHT, Disodium EDTA,
Dipotassium Glycyrrhizate, Phenoxyethanol,
Ethylhexylglycerin, Butylene Glycol, Fragrance.

image description

HYDRATING PROTECTION SUNSCREEN SPF 30  CVS
avobenzone 3.00% homosalate 8.00% octisalate 4.00% octocrylene 4.00% oxybenzone 5.00% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate8 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate4 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene4 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
OAT (UNII: Z6J799EAJK)  
CODIUM TOMENTOSUM (UNII: B8B45BRU87)  
LEVOMENOL (UNII: 24WE03BX2T)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Glycerin (UNII: PDC6A3C0OX)  
Yellow wax (UNII: 2ZA36H0S2V)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 Stearate (UNII: YD01N1999R)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Butylene Glycol (UNII: 3XUS85K0RA)  
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-055-0388 mL in 1 TUBE; Type 0: Not a Combination Product02/16/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/16/2017
Labeler - CVS (062312574)
Registrant - Product Quest Mfg. (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg.927768135manufacture(69842-055)

Revised: 12/2017
Document Id: 14eae8b8-5f47-4fd1-bd34-68c65bdf1f84
Set id: ea5e5f76-24e6-4f0a-a168-cae780ab78bb
Version: 2
Effective Time: 20171226
 
CVS