IMAN TIME CONTROL ALL DAY MOISTURE COMPLEX SPF 15 - octinoxate cream 
Sheencolor Biotech Co., Ltd.

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.

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Drug Fact

Active Ingredients:

7.5% Ethylhexyl Methoxycinnamate, 3.0% Benzophenone-3

This long lasting moisturizing complex, enriched with Vitamin E, Silk Protein, Fruit Acids, and Botanic Extracts, leaves skin soft, supple, and radiant.SPF-15 helps to protect against the harmful effect of the sun.


To Use: Smooth all over face

Warnings:

For external use only, not to be swallowed. Avoid contact with eyes. Discontinue use if signs of irritation or rash appear.


Inactive Ingredients

Water, Cyclopentasiloxane, ethyhexyl Methoxycinnamate, Glycerin, Glyceryl Stearate,Cetyl Palmitate,PPG-3 Benyl Ether Myristate, C12-15 Alkyl Benzoate, Polysorbate 60, PEG-100 Stearate, Tocopheryl Acetate (Vitamin E), Hydrolyzed Wheat Protein, Hydrolyzed Silk, Sodium Hyaluronate, Prunus Armeniaca Fruit Extract, Ginkgo Biloba Leaf Extract, Citric Acid, Aloe Barbadensis Leaf Extract, Aluminum Starch, Octenylsuccinate, Cetyl Alcohol, Triethanolamine, Phenoxyethanol,  Carbomer, Methylparaben, Propylparaben, Isobutylparaben, Butylparaben, Ethylparaben, Disodium EDTA, Fragrance (Parfum)

labellabel

IMAN TIME CONTROL ALL DAY MOISTURE COMPLEX SPF 15 
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50950-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 55.240 g  in 100 g
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 8 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 5.5 g  in 100 g
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 5.5 g  in 100 g
CETYL PALMITATE (UNII: 5ZA2S6B08X) 3.15 g  in 100 g
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ) 1.75 g  in 100 g
POLYSORBATE 60 (UNII: CAL22UVI4M) 1.75 g  in 100 g
POLYOXYL 100 STEARATE (UNII: YD01N1999R) 1.75 g  in 100 g
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.2 g  in 100 g
APRICOT SEED OIL (UNII: 54JB35T06A) 0.05 g  in 100 g
HYALURONATE SODIUM (UNII: YSE9PPT4TH) 0.05 g  in 100 g
GINKGO (UNII: 19FUJ2C58T) 0.05 g  in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.01 g  in 100 g
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 g  in 100 g
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) 0.8 g  in 100 g
CETYL ALCOHOL (UNII: 936JST6JCN) 1 g  in 100 g
TROLAMINE (UNII: 9O3K93S3TK) 0.4 g  in 100 g
CARBOMER HOMOPOLYMER TYPE A (UNII: F68VH75CJC) 0.2 g  in 100 g
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.798 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.17 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.022 g  in 100 g
ISOBUTYLPARABEN (UNII: 0QQJ25X58G) 0.022 g  in 100 g
BUTYLPARABEN (UNII: 3QPI1U3FV8) 0.044 g  in 100 g
ETHYLPARABEN (UNII: 14255EXE39) 0.044 g  in 100 g
EDETATE DISODIUM (UNII: 7FLD91C86K) 0.1 g  in 100 g
ENGLISH LAVENDER OIL (UNII: ZBP1YXW0H8) 0.3 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50950-001-0189 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/10/2010
Labeler - Sheencolor Biotech Co., Ltd. (545285306)
Registrant - Sheencolor Biotech Co., Ltd. (545285306)
Establishment
NameAddressID/FEIBusiness Operations
Sheencolor Biotech Co., Ltd.545285306manufacture

Revised: 8/2010
Document Id: 797f6d37-d5f8-4915-8a7c-a700961acd4d
Set id: e849d3b2-a17b-4cef-9a49-caf7f555191b
Version: 1
Effective Time: 20100805
 
Sheencolor Biotech Co., Ltd.