SUNSCREEN SPF 50- avobenzone 3% homosalate 13% octisalate 5% octocrylene 7% oxybenzone 4% lotion 
Quality Choice

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

3% Avobenzone

13% Homosalate

5% Octisalate

7% Octocrylene

4% Oxybenzone

Purpose

Sunscreen

Uses

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

Inactive Ingredients

Aluminum Starch Octenylsuccinate, Benzyl Alcohol, Carbomer, Dimethicone, Disodium EDTA, Fragrance, Methylparaben, Polyglyceryl-3 Distearate, Propylparaben, Sorbitan Isostearate, Sorbitol, Stearic Acid, Tocopherol, Triethanolamine, VP/Eicosene Copolymer, Water

Other Information

Questions? 248-449-9300

image description

SUNSCREEN SPF 50 
avobenzone 3% homosalate 13% octisalate 5% octocrylene 7% oxybenzone 4% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-786
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE13 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
SORBITOL (UNII: 506T60A25R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TROLAMINE (UNII: 9O3K93S3TK)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-786-06227 g in 1 BOTTLE; Type 0: Not a Combination Product04/11/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/11/2014
Labeler - Quality Choice (011920774)
Registrant - Product Quest Mfg, LLC (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135manufacture(63868-786) , label(63868-786)

Revised: 8/2018
Document Id: ae6e72b8-95a0-48d1-baa3-3ed684e96de3
Set id: dbc5d8c1-07ac-475e-b651-5f2d93131f40
Version: 1
Effective Time: 20180810
 
Quality Choice