Babience KIDS Sunscreen Pinkfong BABY SHARK SPF 50: Package Insert and Label Information

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

Active ingredients

Ensulizole 3.5%

Octinoxate 7.00%

Octisalate 4.5%

Titanium Dioxide 4.57%

Zinc Oxide 11.65%

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 ‚Äčon 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

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
(click image for full-size original)
Babience kids sunscreen spf 50 pinkfong baby shart 50ml box
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2.285 g in 50 mL
ENSULIZOLE (ENSULIZOLE) ENSULIZOLE 1.75 g in 50 mL
OCTINOXATE (OCTINOXATE) OCTINOXATE 3.5 g in 50 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 5.825 g in 50 mL
OCTISALATE (OCTISALATE) OCTISALATE 2.25 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
DICAPRYLYL CARBONATE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
DIMETHICONE
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER
MENTHYL DL-PYRROLIDONECARBOXYLATE
TRIETHOXYCAPRYLYLSILANE
SODIUM BENZOATE
WATER
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)
ZINC STEARATE
SORBITAN SESQUIOLEATE
ALUMINUM HYDROXIDE
DISTEARYLDIMONIUM CHLORIDE (DISTEARYLDIMONIUM)
DIPROPYLENE GLYCOL
TROMETHAMINE
STEARIC ACID
HYDROGEN DIMETHICONE (13 CST)
EDETATE TRISODIUM
SODIUM PYRROLIDONE CARBOXYLATE (PYRROLIDONE CARBOXYLIC ACID)
GLYCERIN
PANTHENOL
GLYCERYL CAPRYLATE
HELIANTHUS ANNUUS SPROUT
ETHYLHEXYLGLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53208-800-01 2 TUBE in 1 BOX contains a TUBE
1 50 mL in 1 TUBE This package is contained within the BOX (53208-800-01)
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 Operations
fmg Co.Ltd 690188305 manufacture (53208-800)

Revised: 12/2021 LG HOUSEHOLD & HEALTH CARE LTD

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