ELF TINTED MOISTURIZER SPF 15- oxybenzone cream

ELF Tinted Moisturizer SPF 15 by

Drug Labeling and Warnings

ELF Tinted Moisturizer SPF 15 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:

Benzophenone-3: 5.0%

Octyl Methoxycinnamate: 7.0%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses:

• Hydrates, softens and smooths skin
  
• Instant natural radiant glow
  
• Helps protect against sun and skin aging
  

WARNINGS

Warning:

For external use only

WHEN USING

When Using This Product:

Do not get into eyes

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:

Massage a pearl-sized amount into skin and neck daily.

STORAGE AND HANDLING

Other Information:

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

INACTIVE INGREDIENT

Inactive Ingredient:

Water, Caprylic/Capric Triglyceride, Kaolin, Titanium Dioxide, Talc, Mica, Octyl Palmitate, Glyceryl Stearate, Synthetic Beeswax,  Stearic Acid, Stearyl Alcohol, DEA-Cetyl Phosphate, Propylene Glycol, Magnesium Aluminum Silicate, Phenoxyehtanol, Triethanolamine, Xanthan Gum, Fragrance, Methylparaben, Propylparaben, Ethylparaben, Disodium EDTA.

May contain:

Iron Oxides (CI 77491, CI 77492, CI 77499)

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

ELF TINTED MOISTURIZER SPF 15 
oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52664-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MICA (UNII: V8A1AW0880)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
KAOLIN (UNII: 24H4NWX5CO)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TALC (UNII: 7SEV7J4R1U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WHITE WAX (UNII: 7G1J5DA97F)
STEARIC ACID (UNII: 4ELV7Z65AP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLPARABEN (UNII: 14255EXE39)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)	42.35 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52664-003-01	12 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