MINERAL WEAR TALC-FREE ILLUMINATING POWDER DUO SPF 16 titanium dioxide zinc

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Physicians Formula Inc

INN (International Name):

ZINC OXIDE

Composition:

ZINC OXIDE 4.2 g in 100 g

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

MINERAL WEAR TALC-FREE ILLUMINATING POWDER DUO SPF 16- TITANIUM
DIOXIDE,
ZINC OXIDE POWDER
PHYSICIANS FORMULA INC
_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: TITANIUM DIOXIDE 12.00%, ZINC OXIDE 4.20%
WARNINGS: FOR EXTERNAL USE ONLY. When using this product, keep out of
eyes. Rinse with water to
remove.
Stop use and ask a doctor if irritation develops and lasts.
KEEP OUT OF REACH OF CHILDREN. If product is swallowed get medical
help or contact a Poison Control
Center right away
MINERAL WEAR TALC-FREE ILLUMINATING POWDER DUO SPF 16
titanium dioxide, zinc oxide powder
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:316 45-154
ROUTE OF ADMINISTRATION
TOPICAL
Physicians Formula Inc
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
4.2 g in 10 0 g
TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9
V2JP)
TITANIUM DIOXIDE
12 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
LAURO YL LYSINE (UNII: 113171Q70 B)
MICA (UNII: V8 A1AW0 8 8 0 )
BO RO N NITRIDE (UNII: 2U4T6 0 A6 YD)
ZINC STEARATE (UNII: H9 2E6 QA4FV)
.ALPHA.-TO CO PHERO L ACETATE, DL- (UNII: WR1WPI7EW8 )
VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)
CHLO RPHENESIN (UNII: I6 70 DAL4SZ)
PO TASSIUM SO RBATE (UNII: 1VPU26 JZZ4)
FERRIC O XIDE RED (UNII: 1K0 9 F3G6 75)
FERRIC O XIDE YELLO W (UNII: EX438 O2MRT)
FERRO SO FERRIC O XIDE (UNII: XM0 M8 7F357)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:316 45-154-0 2
1 in 1 BOX
1
NDC:316 45-154-0 1
10 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt352
0 3/0 1/20 10
LABE