SHU UEMURA FACE ARCHITECT GLOW ENHANCING FOUNDATION SPF 26- octinoxate zinc oxide powder

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

OCTINOXATE 5.74%, ZINC OXIDE 3.41%

Fáanlegur frá:

Cosmelor Ltd

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

OTC DRUG

Ábendingar:

USES: Helps prevent sunburn. Higher SPF give more sunburn protection. DIRECTIONS: For sunscreen benefits, apply evenly before sun exposure.

Leyfisstaða:

OTC monograph not final

Vara einkenni

SHU UEMURA FACE ARCHITECT GLOW ENHANCING FOUNDATION SPF 26- OCTINOXATE
ZINC OXIDE POWDER
COSMELOR 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._
----------
DRUG FACTS
ACTIVE INGREDIENTS
OCTINOXATE 5.74%, ZINC OXIDE 3.41%
USES: DIRECTIONS:
USES: Helps prevent sunburn. Higher SPF give more sunburn protection.
DIRECTIONS: For sunscreen benefits, apply evenly before sun exposure.
WARNINGS:
WARNINGS: FOR EXTERNAL USE ONLY, NOT TO BE SWALLOWED. AVOID CONTACT
WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.
DISCONTINUE USE IF SIGNS OF IRRITATION OR RASH APPEAR. IF IRRITATION
OR RASH
PERSISTS, CONSULT A DOCTOR. KEEP OUT OF REACH OF CHILDREN.
Cosmelor Ltd
SHU UEMURA FACE ARCHITECT GLOW ENHANCING FOUNDATION SPF 26
octinoxate zinc oxide powder
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 8 570 -8 12
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
O CTINO XA TE (UNII: 4Y5P7MUD51) (Octino xate - UNII:4Y5P7MUD51)
O c tino xa te
0 .8 g in 14 g
ZINC O XIDE (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)
Zinc Oxide
0 .48 g in 14 g
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 8 570 -8 12-0 1
1 in 1 CARTON
1
14 g in 1 CONTAINER
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
0 6 /0 1/20 10
LABELER -
Cosmelor Ltd (690725908)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RATIONS
Co smelo r Ltd
6 9 0 7259 0 8
ma nufa c ture
Revised: 6/2010