CORREWAY SUNSCREEN (WATERPROOF) - zinc oxide cream
Ningbo Correway Cosmetics Co., Ltd.

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.

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Drug Facts

Zinc Oxide, Octinoxate, Enzacamene, Avobenzone

Ask Doctor

Stop use and ask a doctor if rash or irritation develops and lasts.
Children under 6 months of age: ask a doctor;

Warning

For external use only;
Avoid contact with eyes;
Stop use and ask a doctor if rash or irritation develops and lasts;
Keep out of reach of children.

Keep out of reach of children

Helps prevent sunburn;
Higher SPF gives more sunburn protection;
Retain SPF after 40 minutes activity in the water;
Rinse with soap to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

Apply liberally before skin exposure;
Reapply as needed after swimming.

CORREWAY SUNSCREEN (WATERPROOF)
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50600-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	80 mg in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	70 mg in 1 g
Enzacamene (UNII: 8I3XWY40L9) (Enzacamene - UNII:8I3XWY40L9)	Enzacamene	35 mg in 1 g
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	10 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Butylene Glycol (UNII: 3XUS85K0RA)
Ceteth-10 (UNII: LF9X1PN3XJ)
Polyoxyl 100 Stearate (UNII: YD01N1999R)
Sorbitan Monooleate (UNII: 06XEA2VD56)
Magnesium Stearate (UNII: 70097M6I30)
Diglycol Stearate (UNII: 94YQ11Y95F)
Magnesium Sulfate Heptahydrate (UNII: SK47B8698T)
Olive Oil (UNII: 6UYK2W1W1E)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Diazolidinylurea (UNII: H5RIZ3MPW4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50600-003-01	42.6 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/23/2010

Labeler - Ningbo Correway Cosmetics Co., Ltd. (529544313)

Registrant - Ningbo Correway Cosmetics Co., Ltd. (529544313)

Name	Address	ID/FEI	Business Operations
Establishment
Ningbo Correway Cosmetics Co., Ltd.		529544313	manufacture