IMAN SKIN TONE EVENER BB SPF 15- oxybenzone cream

Iman Skin Tone Evener BB SPF 15 by

Drug Labeling and Warnings

Iman Skin Tone Evener BB SPF 15 by is a Otc medication manufactured, distributed, or labeled by Impala, Inc., Sheencolor Biotech Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Benzophenone-3: 3%

Octyl methoxycinnamate: 7.5%

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Uses:

Help prevent sunburn

WARNINGS

Warning:

For external use only

Skin Cancer/Skin Aging Alert:

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown to only help prevent sunburn, not skin cancer and skin aging.

Do not use on damaged or broken skin.

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 daily to clean skin, alone or under makeup. Apply over the entire face and neck.

These with sensitive skin should wait 10 minutes after cleansing before application.

Children under 6 months of age, ask a doctor.

STORAGE AND HANDLING

Other Information

Moderate protection against sunburn

INACTIVE INGREDIENT

Inactive Ingredient:

Water (Aqua), Butylene Glycol, Cyclopentasiloxane, Polyglyceryl-3 Diisostearate, Glycerin, Talc, Glyceryl Stearate, PEG-100 Stearate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Garcinia Indica Seed Butter, Rumex Occidentalis Extract,Xanthan Gum, Alcohol Denat, Ascorbic Acid, Euterpe Oleracea Fruit Extract, Aloe Barbadenensis Leaf Juice, Vitis Vinifera (Grape) Seed Oil, Prunus Amygdalus Dulcis (Sweed Almond) Oil, Glycyrrhiza Blabra (Licorice) Root Extract, Tocopheryl Acetate, Retinyl Palmitate, Propyl Glycol, Sodium EDTA, Phenoxyethanol, Methylisothiazolinone.

May Contain: Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, CI 77492, CI 77499)

PRINCIPAL DISPLAY PANEL

lab

INGREDIENTS AND APPEARANCE

IMAN SKIN TONE EVENER BB SPF 15 
oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43438-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ALMOND OIL (UNII: 66YXD4DKO9)
XANTHAN GUM (UNII: TTV12P4NEE)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)	38.83 g  in 100 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
1,2-BUTANEDIOL (UNII: RUN0H01QEU)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ACAI (UNII: 46AM2VJ0AW)
GRAPE SEED OIL (UNII: 930MLC8XGG)
TALC (UNII: 7SEV7J4R1U)
ALCOHOL (UNII: 3K9958V90M)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43438-003-01	30 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/16/2012

Labeler - Impala, Inc. (068545164)

Registrant - Impala, Inc. (068545164)

Establishment
Name	Address	ID/FEI	Business Operations
Sheencolor Biotech Co., Ltd.		545285306	manufacture(43438-003)