UV NATURAL 100 MINERAL SUNKILL RX 2.5G zinc oxide titanium dioxide powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)

Available from:

Nature&Bio Co., Ltd.

INN (International Name):

Zinc Oxide

Composition:

ZINC CATION 0.44 g in 2.5 g

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

UV NATURAL 100 MINERAL SUNKILL RX 2.5G- ZINC OXIDE, TITANIUM DIOXIDE
POWDER
NATURE&BIO 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._
----------
ACTIVE INGREDIENT
Active ingredients: Zinc Oxide 17.9%, Titanium Dioxide 17.3%
INACTIVE INGREDIENT
Inactive ingredients: Mica, Silica, Bismuth Oxychloride, CI 77492, CI
77491, CI 77499, Quartz,
Sapphire Powder
PURPOS E
Purpose: Sunscreen
WARNINGS
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 Rash or irritation develops and lasts,
Keep out of reach of children. If
swallowed, get medical help or contact a Poison Control Center right
away.
KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDREN
INDICATIONS & USAGE
Indications and usage: Helps prevent sunburn, Higher SPF gives
moresunburn protection.
DOSAGE & ADMINISTRATION
Dosage and administration: Apply evenly before sun exposure as needed.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
UV NATURAL 100 MINERAL SUNKILL RX 2.5G
zinc oxide, titanium dioxide powder
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 9 0 58 -0 20
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)
ZINC CATION
0 .44 g in 2.5 g
TITA NIUM DIO XIDE (UNII: 15FIX9 V2JP) (TITANIUM DIOXIDE - UNII:15FIX9
V2JP)
Titanium Dio xide
0 .43 g in 2.5 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
Nature&Bio Co., Ltd.
MICA (UNII: V8 A1AW0 8 8 0 )
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 9 0 58 -0 20 -0 1
2.5 g in 1 CARTON
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 1/20 14
LABELER -
Nature&Bio Co.,