Label: IMAN SKIN TONE EVENER BB SPF 15- oxybenzone cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 43438-003-01 - Packager: Impala, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated August 15, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
-
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
-
INGREDIENTS AND APPEARANCE
IMAN SKIN TONE EVENER BB SPF 15
oxybenzone creamProduct 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)