AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE- avobenzone, homosalate, octisalate, octocrylene lotion 
RETAIL BUSINESS SERVICES, LLC

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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Sunscreen for Babies SPF 50
950.000/950AA

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 4.5%

Octocrylene 8%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

water, glycerin, aluminum starch octenylsuccinate, styrene/acrylates copolymer, behenyl alcohol, glyceryl stearate, benzyl alcohol, PEG-100 stearate, polyester-7, tocopherol, arachidyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, arachidyl glucoside, chlorphenesin, beeswax, silica, neopentyl glycol diheptanoate, potassium hydroxide, disodium EDTA

May stain or damage some fabrics or surfaces

Dist by Foodhold USA, LLC Landover, MD 20733  1877-846-9949

(c)2019 S&S Brands, LLC Quality guaranteed or your money back

*This product is not manufactured or distributed by Bayer, distributor of Coppertone Sunscreen Lotion Water Babies Pure & Simple Broad spectrum SPF 50

**Oxybenzone & Octinoxate free

Principal display panel

CareOne

Compare to Coppertine Sunscreen Lotion Water Babies SPF 50*

Baby Sunscreen Lotion

SPF 50 UVA/UVB protection

Broad Spectrum SPF 50

Water resistant (80 minutes)

Reef friendly

8 FL OZ (236 mL)

image description

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-950
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
DOCOSANOL (UNII: 9G1OE216XY)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POLYESTER-7 (UNII: 0841698D2F)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
neopentyl glycol diheptanoate (UNII: 5LKW3C543X)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-950-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/08/2019
Labeler - RETAIL BUSINESS SERVICES, LLC (967989935)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(72476-950)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon088520668manufacture(72476-950)

Revised: 4/2023
Document Id: 32d487f7-3fdd-4f2d-b8ef-0fcb501f280c
Set id: 1dc325bb-d520-4897-b8f8-3f0ecba2274c
Version: 3
Effective Time: 20230420
 
RETAIL BUSINESS SERVICES, LLC