ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION- titanium dioxide powder

ELF SPF 45 Sunscreen UVA/UVB Protection by

Drug Labeling and Warnings

ELF SPF 45 Sunscreen UVA/UVB Protection by is a Otc medication manufactured, distributed, or labeled by Hangzhou Facecare Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Titanium Dioxide: 21.25%

Zinc Oxide: 17%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses:

Help prevent sunburns

Higher SPF gives more sunburn protection

WARNINGS

Warning:

For external use only

WHEN USING

When Using This Product:

Keep out of eyes. Rinse with water to remove.

ASK DOCTOR

Stop Use and Ask a Doctor if:

Rash or irritation develops and lasts

KEEP OUT OF REACH OF CHILDREN

Keep Out of Reach of Children:

If swallowed get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION

Directions:

Apply as needed for 15-20 minutes of sun exposure

STORAGE AND HANDLING

Other Imformation:

Store at room temperature 15-30C (59-86F)

INACTIVE INGREDIENT

Inactive Ingredient:

Mica, Silica, Talc, Bismuth Oxychloride, Boron Nitride, Aluminum Hydroxide, Sodium Dehydroacetate, Vitis Vinifera (Grape) Seed Extract, Aloe Barbadensis Leaf Extract, Retinyl Palmitate (VA), Tocopheryl Acetate (VE)

May contain:

Iron Oxides (CI 77491, CI 77492, CI 77499), Manganese Violet (CI 77742)

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

ELF SPF 45 SUNSCREEN UVA/UVB PROTECTION 
titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52664-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	21.25 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GRAPE SEED OIL (UNII: 930MLC8XGG)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52664-010-01	10 g in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/01/2010

Labeler - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)

Registrant - Hangzhou Facecare Cosmetics Co., Ltd. (545341856)

Establishment
Name	Address	ID/FEI	Business Operations
Hangzhou Facecare Cosmetics Co., Ltd.		545341856	manufacture