HYDRO SPLASH BB SPF20 PA- titanium dioxide cream

HYDRO SPLASH BB by

Drug Labeling and Warnings

HYDRO SPLASH BB by is a Otc medication manufactured, distributed, or labeled by THEFACESHOP CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: TITANIUM DIOXIDE

INACTIVE INGREDIENT

Inactive ingredients:

WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, CYCLOHEXASILOXANE, GLYCERIN, ALCOHOL DENAT., DIMETHICONE, TALC, NEOPENTYL GLYCOL DIETHYLHEXANOATE,
PEG-10 DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, SODIUM CHLORIDE, SORBITAN SESQUIOLEATE, METHYLPARABEN, PEG-7 DIMETHICONE, FRAGRANCE, TRIETHOXYCAPRYLYLSILANE, ALUMINUM HYDROXIDE, IRON OXIDES(CI 77491), IRON OXIDES(CI 77492), STEARIC ACID, IRON OXIDES(CI 77499), PROPYLPARABEN, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, PORTULACA OLERACEA EXTRACT, OENOTHERA BIENNIS (EVENING PRIMROSE) FLOWER EXTRACT, ALOE FEROX LEAF EXTRACT

DESCRIPTION

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.
Children under 6months of age; ask a doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDRO SPLASH BB  SPF20 PA
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51523-012
Route of Administration	CUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE)	TITANIUM DIOXIDE	4.48 g  in 45 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51523-012-01	45 g in 1 CARTON

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

Labeler - THEFACESHOP CO., LTD. (688329416)