HYDRATING PROTECTION SUNSCREEN SPF 50 CVS- avobenzone 3.00% homosalate 10.00% octisalate 5.00% octocrylene 6.00% oxybenzone 5.00% lotion

Hydrating Protection Sunscreen SPF 50 by

Drug Labeling and Warnings

Hydrating Protection Sunscreen SPF 50 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 10%..................................................................Sunscreen
Octisalate 5%.......................................................................Sunscreen
Octocrylene 6%..............................................................  ....Sunscreen
Oxybenzone 5%............................................................ ......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

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

INGREDIENTS AND APPEARANCE

HYDRATING PROTECTION SUNSCREEN SPF 50   CVS
avobenzone 3.00% homosalate 10.00% octisalate 5.00% octocrylene 6.00% oxybenzone 5.00% lotion

Product 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)