Drug Facts

FLEBEAUTE COLLAGENIC TWO WAY CAKE SPF17 PA NB21- titanium dioxide powder
THEFACESHOP CO., 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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Drug Facts

Active Ingredients: TITANIUM DIOXIDE, ZINC OXIDE

Inactive Ingredients:

MICA(CI 77019), TALC, SILICA, SQUALANE, ALUMINA MAGNESIUM MYRISTATE, NYLON-12, BARIUM SULFATE, BORON NITRIDE, ETHYLHEXYL METHOXYCINNAMATE, DIMETHICONE, LAUROYL LYSINE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE, CROSSPOLYMER, IRON OXIDES(CI 77492), CAPRYLIC/CAPRIC TRIGLYCERIDE, METHICONE, MAGNESIUM STEARATE, HYDROGENATED LECITHIN, IRON OXIDES(CI 77491), METHYLPARABEN, FRAGRNACE, BUTYLPARABEN, IRON OXIDES(CI 77499), BUTYLENE GLYCOL, HYDROLYZED EXTENSIN, WATER, ULTRAMARINES(CI 77007), CROCUS SATIVUS FLOWER EXTRACT, PHENOXYETHANOL, ARTEMISIA ABROTANUM FLOWER/LEAF/STEM EXTRACT, TRIETHOXYCAPRYLYLSILANE

Warnings:
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.

Directions:
Apply evenly before sun exposure and as needed.

Image of carton

FLEBEAUTE COLLAGENIC TWO WAY CAKE SPF17 PA NB21
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51523-009
Route of Administration	CUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	0.93 g in 12 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC OXIDE	0.17 g in 12 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51523-009-01	12 g in 1 CARTON

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	07/01/2008

Labeler - THEFACESHOP CO., LTD. (688329416)