CORREWAY SUNSCREEN (NON-WATERPROOF)- octinoxate cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Octinoxate, Octisalate, Oxybenzone, Avobenzone 

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

DO NOT USE

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;

PURPOSE

Helps prevent sunburn;
Higher SPF gives more sunburn protection;
Rinse with water to remove;

WHEN USING

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

STOP USE

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

PRINCIPAL DISPLAY PANEL

Active Ingredients                                             Purpose
Octinoxate          7.50%    ………………………………… Absorb/Reflect UV rays
Octisalate          5.00%    ………………………………… Absorb/Reflect UV rays
Oxybenzone          3.50%    ………………………………… Absorb/Reflect UV rays
Avobenzone          3.50%    ………………………………… Absorb/Reflect UV rays
Uses:
■ Helps prevent sunburn;
■ Higher SPF gives more sunburn protection;
■ Rinse with water to remove
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
Directions for use:
■ Apply liberally before skin exposure;
■ Children under 6 months of age: ask a doctor;
■ Reapply as needed after swimming.
Inactive Ingredients:
Water, Glycerin, Cetostearyl Alcohol, Glyceryl Monostearate, Cyclomethicone, Polysorbate 80
Ethylhexyl Palmitate, Sodium Lauryl Sulfate, Carbomer 934, Trolamine, Methylparaben, Propylparaben
Diazolidinylurea

Distributed By:
ePromos Promotional Products, Inc.
ph: 212 457 3906


Made in China

INGREDIENTS AND APPEARANCE

CORREWAY SUNSCREEN (NON-WATERPROOF) 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50600-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	35 mg  in 1 g
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	35 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Cyclomethicone (UNII: NMQ347994Z)
Polysorbate 80 (UNII: 6OZP39ZG8H)
Ethylhexyl Palmitate (UNII: 2865993309)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Carbomer 934 (UNII: Z135WT9208)
Trolamine (UNII: 9O3K93S3TK)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Diazolidinyl Urea (UNII: H5RIZ3MPW4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50600-004-01	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	07/20/2010

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