BABIENCE KIDS SUNSCREEN PINKFONG BABY SHARK SPF 50- ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide lotion

Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50 by

Drug Labeling and Warnings

Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50 by is a Otc medication manufactured, distributed, or labeled by LG HOUSEHOLD & HEALTH CARE LTD, fmg Co.Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Zinc Oxide 11.65%

Octinoxate 7.00%

Titanium Dioxide 4.57%

Octisalate 4.5%

Ensulizole 3.5%

Purpose

Sunscreen

USES

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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:

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistent sunscreen if swimming or sweating
• children under 6 months of age: Ask a doctor

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

BABIENCE KIDS SUNSCREEN PINKFONG BABY SHARK SPF 50 
ensulizole, octinoxate, octisalate, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53208-800
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.285 g  in 50 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1.75 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.825 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.25 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53208-800-01	2 in 1 BOX	04/27/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/27/2020

Labeler - LG HOUSEHOLD & HEALTH CARE LTD (688276187)

Establishment
Name	Address	ID/FEI	Business Operations
fmg Co.Ltd		690188305	manufacture(53208-800)