SEBORRHEIC PURIFYING- octinoxate cream 
Zenith Medicosm SL

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 Facts

Active Ingredient

Octinoxate 7.5%

Description

A gel-like cream containing biosulfur, hamamelis (witch hazel) and vitamin B that balances the skin's oil levels and combats the bacteria that cause pore blocking, micro cysts and papules. It regulates the hydro lipid mantle and reduces oiliness. Especially indicated for young and oily and/or acned skins.

50ml. 1.7 fl. Oz


Warning

TOPICAL USE

SEBORRHEICPURIFYING
SEBORRHEIC  PURIFYING
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.75 mL  in 50 mL
Inactive Ingredients
Ingredient NameStrength
LANOLIN (UNII: 7EV65EAW6H)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TALC (UNII: 7SEV7J4R1U)  
THYME (UNII: CW657OBU4N)  
ALOE (UNII: V5VD430YW9)  
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
TRICLOSAN (UNII: 4NM5039Y5X)  
PEG-8 STEARATE (UNII: 2P9L47VI5E)  
TROLAMINE (UNII: 9O3K93S3TK)  
LEVOMENOL (UNII: 24WE03BX2T)  
SULFUR (UNII: 70FD1KFU70)  
YEAST (UNII: 3NY3SM6B8U)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
CARBOMER 934 (UNII: Z135WT9208)  
ALLANTOIN (UNII: 344S277G0Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42248-108-021 in 1 BOX
150 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/15/2011
Labeler - Zenith Medicosm SL (464239694)
Registrant - Zenith Medicosm SL (464239694)
Establishment
NameAddressID/FEIBusiness Operations
Zenith Medicosm SL464239694manufacture

Revised: 1/2012
Document Id: 3d7512ce-c32f-4f7f-aea4-ecfa459d7881
Set id: 09293268-c61e-4094-bb72-a81be5f98da2
Version: 4
Effective Time: 20120121
 
Zenith Medicosm SL