MEDISPA SUNBLOCK SUNBLOCK- zinc oxide cream 
Universal Cosmetic Co., Ltd

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.

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Drug Facts

Active Ingredients: Ethylhexyl Methoxycinnamate, Zinc Oxide, 4-Methylbenzylidene camphor, Butyl Mehoxydibenzoylmethane

Uses
■ 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

box label
MEDISPA SUNBLOCK  SUNBLOCK
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52554-1001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.05 mL  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 mL  in 1 mL
ENZACAMENE (UNII: 8I3XWY40L9) (ENZACAMENE - UNII:8I3XWY40L9) ENZACAMENE0.03 mL  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.005 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52554-1001-170 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/04/2010
Labeler - Universal Cosmetic Co., Ltd (557795012)

Revised: 8/2010
Document Id: ad7e144f-288c-4513-86f1-c9d82bd80359
Set id: 2eda1a2b-e024-449b-9553-839cdad9aab3
Version: 1
Effective Time: 20100804
 
Universal Cosmetic Co., Ltd