IMAN SKIN TONE EVENER BB SPF 15 - oxybenzone cream 
Impala, 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 Fact

Active Ingredient:

Benzophenone-3: 3%

Octyl methoxycinnamate: 7.5%

Purpose:

Sunscreen

Uses:

Help prevent sunburn

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 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 immediately.

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.


Other Information

Moderate protection against sunburn

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)

lablabel

IMAN SKIN TONE EVENER BB SPF 15 
oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43438-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43438-003-0130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/16/2012
Labeler - Impala, Inc. (068545164)
Registrant - Impala, Inc. (068545164)
Establishment
NameAddressID/FEIBusiness Operations
Sheencolor Biotech Co., Ltd.545285306manufacture(43438-003)

Revised: 8/2012
Document Id: afbde6f2-25d3-4898-9435-02cbf8f1aa69
Set id: 8afbb956-f24d-42f8-b197-e8d341f8462c
Version: 1
Effective Time: 20120815
 
Impala, Inc.