Label: MEDISPA SUNBLOCK SUNBLOCK- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 52554-1001-1 - Packager: Universal Cosmetic Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated August 4, 2010
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active Ingredients: Ethylhexyl Methoxycinnamate, Zinc Oxide, 4-Methylbenzylidene camphor, Butyl MehoxydibenzoylmethaneUses
■ Perfectly blocks both UVA and UVB rays without stimuli
■ Provides high protection from sunburn
■ Suitable for skin that underwent medical treatment
Warning
For external use only
When using this product
■ Avoid eye area. If contact occurs, rinse eyes thoroughly
■ Discontinue use if signs of irritation develops
Keep out of reach of the children
Direction
■ Rub a proper quantity over the whole face, before finishing skincare.
Other Information
■ store between 20-25 °C (68-77 °F)
■ avoid freezing and excessive heat above 40 °C (104 °F)
■ close cap after use.
Inactive Ingredient
■ Water ■ Cyclomethicone ■ Dimethicone/Vinyl Dimethicone Crosspolymer ■ C12-15 Alkyl Benzoate ■ Glycerin ■ Cetyl PEG/PPG-10/1 Dimethicone ■ Beeswax ■ Sodium Chloride ■ Sorbitan Sesquiolate ■ C20-40 acid ■ Methylparaben ■ Polyethylene ■ Brassica Campestris Sterols ■ Propylparaben ■ Disodium EDTA
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MEDISPA SUNBLOCK SUNBLOCK
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52554-1001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 0.05 mL in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.07 mL in 1 mL ENZACAMENE (UNII: 8I3XWY40L9) (ENZACAMENE - UNII:8I3XWY40L9) ENZACAMENE 0.03 mL in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.005 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52554-1001-1 70 mL in 1 BOTTLE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/04/2010 Labeler - Universal Cosmetic Co., Ltd (557795012)
