CORREWAY SUNSCREEN (WATERPROOF)- zinc oxide cream

Correway Sunscreen (Waterproof) by

Drug Labeling and Warnings

Correway Sunscreen (Waterproof) by is a Otc medication manufactured, distributed, or labeled by Ningbo Correway Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

Keep out of reach of children

PURPOSE

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

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

WHEN USING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CORREWAY SUNSCREEN (WATERPROOF) 
zinc oxide cream

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

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

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

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