SUNSCREEN SPF 30- avobenzone 3.0% homosalate 10.0% octisalate 5.0% octocrylene 10.0% lotion 
CareOne

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

Actives

Avobenzone 3.0%

Homosalate 10.0%

Octisalate 5.0%

Octocrylene 10.0%

​​​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 or irritation develops and lasts

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Caprylic/Capric Triglyceride, Chlorphenesin, Diethylhexyl Syringylidemaionate, Disodium EDTA, Ethylhexyl Palmitate, Fragrance, Oieth-3, Polyamide-8, Retinyl Palmitate, Sodium Ascorbyl Phosphate, Sorbitol, Tocopherol, Triethanolamine, Water.

image description

SUNSCREEN SPF 30 
avobenzone 3.0% homosalate 10.0% octisalate 5.0% octocrylene 10.0% lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-347
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 COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
OLETH-3 (UNII: BQZ26235UC)  
NEOPENTYL GLYCOL (UNII: QI80HXD6S5)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
SORBITOL (UNII: 506T60A25R)  
TOCOPHEROL (UNII: R0ZB2556P8)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-347-06237 mL in 1 BOTTLE; Type 0: Not a Combination Product01/25/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/25/2017
Labeler - CareOne (809183973)
Registrant - Product Quest Mfg, LLC (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135manufacture(41520-347) , label(41520-347)

Revised: 7/2018
Document Id: 567a7982-87b2-40d7-aca9-e47d470239a0
Set id: 9fb397ae-9872-416f-8bfe-c7e00d32a7a0
Version: 1
Effective Time: 20180716
 
CareOne