MEDISPA SUNBLOCK SUNBLOCK- zinc oxide cream

MediSpa Sunblock by

Drug Labeling and Warnings

MediSpa Sunblock by is a Otc medication manufactured, distributed, or labeled by Universal Cosmetic Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDISPA SUNBLOCK  SUNBLOCK
zinc oxide cream

Product 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)