BABIENCE KIDS SUNSCREEN PINKFONG BABY SHARK SPF 50- ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide lotion 
LG HOUSEHOLD & HEALTH CARE LTD

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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Babience KIDS Sunscreen SPF 50 pinkfong BABY SHARK 50ml

Active ingredients

Ensulizole 3.5%

Octinoxate 7.00%

Octisalate 4.5%

Titanium Dioxide 4.57%

Zinc Oxide 11.65%

Purpose

Sunscreen

USES

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

Inactive ingredients

WATER, CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL, GLYCERIN, DICAPRYLYL CARBONATE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TROMETHAMINE, DIMETHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, PANTHENOL, DISTEARDIMONIUM HECTORITE, ALUMINUM HYDROXIDE, ZINC STEARATE, SORBITAN SESQUIOLEATE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, STEARIC ACID, GLYCERYL CAPRYLATE, HYDROGEN DIMETHICONE, DISTEARYLDIMONIUM CHLORIDE, ETHYLHEXYLGLYCERIN, TRIETHOXYCAPRYLYLSILANE, TRISODIUM EDTA, HELIANTHUS ANNUS (SUNFLOWER) SRPOUT EXTRACT, MENTHYL PCA, SODIUM PCA, SODIUM BENZOATE, TITANIUM DIOXIDE (CI 77891), FRAGRANCE

Other information

Protect this product in this container from excessive heat and direct sun

U.S.A./E.-U.: 1-800-FOR-AVON www.avon.com

PRINCIPAL DISPLAY PANEL

Babience
KIDS
Sunscreen
Broad Spectrum
SPF 50
50 ml / 1.69 fl. oz.
pinkfong

BABY SHARK

1-800-FOR-AVON www.avon.com

MADE IN KOREA

DIST. NEW AVON LLC, NEW YORK, NY 1006

Babience kids sunscreen spf 50 pinkfong baby shart 50ml tube

Babience kids sunscreen spf 50 pinkfong baby shart 50ml box

BABIENCE KIDS SUNSCREEN PINKFONG BABY SHARK SPF 50 
ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53208-800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.285 g  in 50 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE1.75 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.5 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5.825 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
MENTHYL DL-PYRROLIDONECARBOXYLATE (UNII: 8P18J856U2)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
ZINC STEARATE (UNII: H92E6QA4FV)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
TROMETHAMINE (UNII: 023C2WHX2V)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL (UNII: WV9CM0O67Z)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53208-800-012 in 1 BOX04/27/2020
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/27/2020
Labeler - LG HOUSEHOLD & HEALTH CARE LTD (688276187)
Establishment
NameAddressID/FEIBusiness Operations
fmg Co.Ltd690188305manufacture(53208-800)

Revised: 12/2021
Document Id: d308036f-0f49-3deb-e053-2a95a90a9f53
Set id: a4364c8d-8b74-130e-e053-2995a90ad1c1
Version: 2
Effective Time: 20211213
 
LG HOUSEHOLD & HEALTH CARE LTD