BRUCKE A.C.C. CALMING COOL SUNCREAM- ethylhexyl methoxycinnamate, titanium dioxide cream

BRUCKE A.C.C. CALMING COOL SUNCREAM by

Drug Labeling and Warnings

BRUCKE A.C.C. CALMING COOL SUNCREAM by is a Otc medication manufactured, distributed, or labeled by Nature4 co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ethylhexyl Methoxycinnamate(Octinoxate), Titanium Dioxide

INACTIVE INGREDIENT

Water, 1,2-Hexanediol, etc

PURPOSE

Helps prevent sunburn.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

Apply a sufficient amount to cover the exposed area thoroughly.

WARNINGS

1. In case of having side effects such as red rash, swollenness and/or itching while using this cosmetic, or in case such symptoms appear by direct sunlight after using it, consult a dermatologist immediately.
2. Do not apply on skin where there is wound, eczema, or irritation.
3. Storage and cautions for handling.
A) Keep out of reach of children.
B) Avoid the place where the direct sunlight is.
4. If the cream put on your cloth, do not wash and dry cleaning.

DOSAGE & ADMINISTRATION

for external use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BRUCKE A.C.C. CALMING COOL SUNCREAM 
ethylhexyl methoxycinnamate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71380-0014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.6736 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.2 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: 71380-0014-1	50 mL in 1 TUBE; Type 0: Not a Combination Product	12/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/03/2019

Labeler - Nature4 co., Ltd. (694208420)

Registrant - Nature4 co., Ltd. (694208420)

Establishment
Name	Address	ID/FEI	Business Operations
Nature4 co., Ltd.		694208420	manufacture(71380-0014)