AVOBENZONE 3% HOMOSALATE 10% OCTISALATE 5% OCTOCRYLENE 10%- hydrating spf 30 lotion
Walgreens

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

Uses • helps prevent sunburn • higher SPF gives more sunburn
protection • retains SPF after 80 minutes of activity in the water or
sweating • provides high protection against 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 or irritation develops and lasts.

Other information • protect the product in this container
from excessive heat and direct sun • may stain fabrics.

Inactive ingredients Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Aloe Barbadensis Leaf Extract, Benzyl Alcohol,
Caprylic/Capric Triglyceride, Chlorphenesin, Diethylhexyl
Syringylidenemalonate, Disodium EDTA, Ethylhexyl Palmitate,
Fragrance, Glycerin, Oleth-3, Polyamide-8, Retinyl Palmitate, Sodium
Ascorbyl Phosphate, Sorbitol, Tocopherol, Triethanolamine, Water.

Questions? 1-800-925-4733

image description

AVOBENZONE 3% HOMOSALATE 10% OCTISALATE 5% OCTOCRYLENE 10%
hydrating spf 30 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-1122
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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	10 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Benzyl Alcohol (UNII: LKG8494WBH)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
Chlorphenesin (UNII: I670DAL4SZ)
Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Ethylhexyl Palmitate (UNII: 2865993309)
Glycerin (UNII: PDC6A3C0OX)
Oleth-3 (UNII: BQZ26235UC)
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
Sodium Ascorbyl Phosphate (UNII: 836SJG51DR)
Sorbitol (UNII: 506T60A25R)
Tocopherol (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0363-1122-06	236 mL in 1 TUBE; Type 0: Not a Combination Product	11/16/2016	04/16/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/16/2016	04/16/2018

Labeler - Walgreens (008965063)

Registrant - Product Quiest Mfg (927768135)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quiest Mfg		927768135	manufacture(0363-1122) , label(0363-1122)

Revised: 4/2018

Document Id: 3c96cb40-961a-4f1c-8c0a-84bfc87d556b

Set id: 78bcd5f9-0ff4-4a48-8fbc-6304e2a7f6d5

Version: 2

Effective Time: 20180417

Walgreens