Search by Drug Name or NDC

NDC 72330-0800-01 Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50 1.75; 3.5; 2.25; 2.285; 5.825 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL Details

Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50 1.75; 3.5; 2.25; 2.285; 5.825 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL

Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50 is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by fmg Co.Ltd. The primary component is ENSULIZOLE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	72330-0800
Product ID	72330-800_d31f4e71-ad05-d2df-e053-2a95a90a7e24
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Babience KIDS Sunscreen pinkfong BABY SHARK SPF 50
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ensulizole, Octinoxate, Octisalate, Titanium Dioxide, Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	1.75; 3.5; 2.25; 2.285; 5.825
Active Ingredient Units	g/50mL; g/50mL; g/50mL; g/50mL; g/50mL
Substance Name	ENSULIZOLE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	fmg Co.Ltd
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 72330-0800-01 (72330080001)

Pricing Information	N/A
NDC Package Code	72330-800-01
Billing NDC	72330080001
Package	2 TUBE in 1 BOX (72330-800-01) / 50 mL in 1 TUBE
Marketing Start Date	2020-04-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d2fadd51-6bd8-ae70-e053-2995a90a6213 Details

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 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:72330-800
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72330-800-01	2 in 1 BOX	04/27/2020
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - fmg Co.Ltd (690188305)

Registrant - LG HOUSEHOLD & HEALTH CARE LTD (688276187)

Name	Address	ID/FEI	Business Operations
Establishment
fmg Co.Ltd		690188305	manufacture(72330-800)

Revised: 12/2021

Document Id: d31f4e71-ad05-d2df-e053-2a95a90a7e24

Set id: d2fadd51-6bd8-ae70-e053-2995a90a6213

Version: 2

Effective Time: 20211212