Drug Labeling and Warnings

Drug Details [pdf]

BATURE UV PROTECT SUNSCREEN- zinc oxide, titanium dioxide cream 
GC US CORPORATION

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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Active ingredients

Zinc Oxide 11.12%

Titanium Dioxide 2.83%

Sunscreen

Uses

• Helps prevent sunburn
• higher SPF gives more sunburn protection
• If used as directed with other sun protection measures [see Directions], decrease and early skin aging caused by the sun

Warnings

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 a doctor if

rash or irritation develops and lasts

Keep out of reach of children.

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

Directions

• Apply generously and evenly as needed
• Apply liberally 15 minutes before sun exposure
• Reapply as needed
• Children under 6 months of age: Ask a doctor

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Cyclopentasiloxane, Butyloctyl Salicylate, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, PEG-10 Dimethicone, Dipropylene Glycol, C12-15 Alkyl Benzoate, Niacinamide, Methyl Methacrylate Crosspolymer, Cyclomethicone, Hydrogenated Polydecene, Disteardimonium Hectorite, Sorbitan Olivate, Sodium Chloride, Dimethicone/Methicone Copolymer, Silica, Polysilicone-11, Sorbitan Sesquioleate, Camellia Japonica Seed Oil, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Polyhydroxystearic Acid, Stearic Acid, Glycyrrhiza Glabra (Licorice) Root Extract, Cucumis Sativus (Cucumber) Fruit Extract, Portulaca Oleracea Extract, Poria Cocos Extract, Pisum Sativum (Pea) Extract, Butylene Glycol, Polylysine, Fragrance, Adenosine

Questions?

• side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Net Wt. 1.69oz/50g

Manufactured for BEAUTY BAKERY Inc.

3F, Jaerim Bldg. 91-1 Cheongdam-dong, Gangnam-gu, Seoul, Korea 06016

MADE IN KOREA/Fabriqué en Corée

BATURE UV PROTECT SUNSCREEN 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71454-3645
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	5.56 g  in 50 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.42 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
LYSINE (UNII: K3Z4F929H6)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
ADENOSINE (UNII: K72T3FS567)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
CUCUMBER (UNII: YY7C30VXJT)
PURSLANE (UNII: M6S840WXG5)
FU LING (UNII: XH37TWY5O4)
PEA (UNII: W4X7H8GYFM)
WATER (UNII: 059QF0KO0R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
NIACINAMIDE (UNII: 25X51I8RD4)
CYCLOMETHICONE (UNII: NMQ347994Z)
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
SORBITAN OLIVATE (UNII: MDL271E3GR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71454-3645-2	1 in 1 CARTON	08/15/2017	09/22/2019
1		60 g 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	08/15/2017	09/22/2019

Labeler - GC US CORPORATION (080669481)

Revised: 8/2017

Document Id: 543eed82-c93a-01c1-e054-00144ff88e88

34390-5

Set id: 543eed82-c94a-01c1-e054-00144ff88e88

Version: 1

Effective Time: 20170831