HYDRATING PROTECTION SUNSCREEN CVS- avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% oxybenzone 6.0% lotion

Hydrating Protection Sunscreen by

Drug Labeling and Warnings

Hydrating Protection Sunscreen by is a Otc medication manufactured, distributed, or labeled by CVS, Product Quest Mfg.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients                                                               Purpose
Avobenzone 3%...................................................................Sunscreen
Homosalate 15%..................................................................Sunscreen
Octisalate 5%.......................................................................Sunscreen
Octocrylene 10%..................................................................Sunscreen
Oxybenzone 6%..................................................... .............Sunscreen

PURPOSE

INDICATIONS & USAGE

Uses helps prevent sunburn

WARNINGS

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

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

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

INGREDIENTS AND APPEARANCE

HYDRATING PROTECTION SUNSCREEN  CVS
avobenzone 3.0% homosalate 15.0% octisalate 5.0% octocrylene 10.0% oxybenzone 6.0% lotion

Product 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)