HYDRATING PROTECTION SUNSCREEN CVS- avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% oxybenzone 6.0% 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 15%..................................................................Sunscreen
Octisalate 5%.......................................................................Sunscreen
Octocrylene 10%..................................................................Sunscreen
Oxybenzone 6%..................................................... .............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

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

image description

HYDRATING PROTECTION SUNSCREEN  CVS
avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% oxybenzone 6.0% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-054
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) Homosalate15 g  in 100 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene10 g  in 100 mL
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69842-054-0388 mL in 1 PACKAGE; 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(69842-054)

Revised: 12/2017
Document Id: 2a7620c4-d556-40be-b1c3-f76598a1eb31
Set id: 4d500050-6af9-444e-9845-3abe3e025abe
Version: 2
Effective Time: 20171212
 
CVS