HYDRATING SPF 30- avobenzone 3% homosalate 10% octisalate 5% octocrylene 10% 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

HYDRATING SPF 30 
avobenzone 3% homosalate 10% octisalate 5% octocrylene 10% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1124
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) Homosalate10 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
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-1124-06236 mL in 1 TUBE; Type 0: Not a Combination Product11/16/2016
2NDC:0363-1124-0389 mL in 1 TUBE; Type 0: Not a Combination Product11/16/2016
3NDC:0363-1124-07296 mL in 1 TUBE; Type 0: Not a Combination Product11/16/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/16/2016
Labeler - Walgreens (008965063)
Registrant - Product Quiest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quiest Mfg927768135manufacture(0363-1124) , label(0363-1124)

Revised: 4/2018
Document Id: eceadfed-27fb-46b5-9161-fbdf008068a4
Set id: c8c67a49-fe6a-43d2-ae43-7007b3128851
Version: 2
Effective Time: 20180430
 
Walgreens