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

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

Dostupno od:

Nature4 co., Ltd.

Administracija rute:

TOPICAL

Tip recepta:

OTC DRUG

Terapijske indikacije:

Helps prevent sunburn. Apply a sufficient amount to cover the exposed area thoroughly.

Status autorizacije:

OTC monograph not final

Svojstava lijeka

BRUCKE A.C.C. CALMING COOL SUNCREAM- ETHYLHEXYL METHOXYCINNAMATE,
TITANIUM
DIOXIDE CREAM
NATURE4 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._
----------
NATURE4 CO., LTD. - BRUCKE A.C.C. CALMING COOL SUNCREAM
Ethylhexyl Methoxycinnamate(Octinoxate), Titanium Dioxide
Water, 1,2-Hexanediol, etc
Helps prevent sunburn.
keep out of reach of the children
Apply a sufficient amount to cover the exposed area thoroughly.
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.
for external use only
BRUCKE A.C.C. CALMING COOL SUNCREAM
ethylhexyl methoxycinnamate, titanium dioxide cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:7138 0 -0 0 14
ROUTE OF ADMINISTRATION
TOPICAL
Nature4 co., Ltd.
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9
V2JP)
TITANIUM DIOXIDE
2.6 736 g in 10 0 mL
O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)
OCTINOXATE
7.2 g in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:7138 0 -0 0 14-1
50 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct
12/0 3/20 19
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt352
12/0 3/20 19
LABELE