Label: OHUI SUN SCIENCE INTENSIVE SUNBLOCK CAKE EX- zinc oxide, octinoxate, titanium dioxide, bemotrizinol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 53208-473-01, 53208-473-02 - Packager: LG Household and Healthcare, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated July 16, 2010
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- ACTIVE INGREDIENT
- WARNINGS AND PRECAUTIONS
- Keep out of reach of children
- STOP USE
- WHEN USING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OHUI SUN SCIENCE INTENSIVE SUNBLOCK CAKE EX
zinc oxide, octinoxate, titanium dioxide, bemotrizinol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53208-473 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10.528 g in 100 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4 g in 100 g BEMOTRIZINOL (UNII: PWZ1720CBH) (BEMOTRIZINOL - UNII:PWZ1720CBH) BEMOTRIZINOL 1.5 g in 100 g Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE (UNII: NMQ347994Z) CYCLOMETHICONE (UNII: NMQ347994Z) METHYLPARABEN (UNII: A2I8C7HI9T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53208-473-02 2 in 1 BOX 1 NDC:53208-473-01 15 g in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/16/2010 Labeler - LG Household and Healthcare, Inc. (688276187) Registrant - LG Household and Healthcare, Inc. (688276187) Establishment Name Address ID/FEI Business Operations LG Household and Healthcare, Inc. 688276187 manufacture