HYDRO SPLASH BB SPF20 PA

Dosage form: cream
Ingredients: TITANIUM DIOXIDE 4.48g in 45g
Labeler: THEFACESHOP CO., LTD.
NDC Code: 51523-012

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.

Drug Facts

Active Ingredient: TITANIUM DIOXIDE

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

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.

HYDRO SPLASH BB  SPF20 PA
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51523-012
Route of AdministrationCUTANEOUSDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM) TITANIUM DIOXIDE4.48 g  in 45 g
Packaging
#Item CodePackage Description
1NDC:51523-012-0145 g in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/01/2008
Labeler - THEFACESHOP CO., LTD. (688329416)

Revised: 07/2010
 
THEFACESHOP CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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