DR NIKKO SHEER SUNSCREEN- octinoxate cream

DR NIKKO SHEER SUNSCREEN by

Drug Labeling and Warnings

DR NIKKO SHEER SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Cit Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

octinoxate, octisalate, ensulizole

INACTIVE INGREDIENT

water, glycerin, dipropylene glycol, etc.

PURPOSE

helps prevent sunburn

WARNINGS

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
1) Occurrence of red spots, swelling, itchiness, and other irritation
2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other irritations
3. Precaution for Storage and Handling
1) Close the lid after use
2) Keep out of reach of infants and children
3) Do not to store in a place with high/low temperature and exposed to direct sunlight

4. Use as avoiding eye areas.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

Apply liberally 15 minutes before sun exposure

DOSAGE & ADMINISTRATION

external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR NIKKO SHEER SUNSCREEN 
octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69133-050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	2 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69133-050-01	50 mL in 1 TUBE; Type 0: Not a Combination Product	08/13/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/13/2018

Labeler - Cit Co., Ltd. (690081646)

Registrant - Cit Co., Ltd. (690081646)

Establishment
Name	Address	ID/FEI	Business Operations
Cit Co., Ltd.		690081646	label(69133-050) , manufacture(69133-050)