FIRMING AND MOISTURIZING BODY- octinoxate emulsion 
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

SUN CARE CREAM FOR BODY

SPF 25

MEDIUM PROTECTION

UVA - UVB - WATER RESISTANT


Body emulsion rich in anti-age ingredients.  Its formula protects skin from UVB and UVA rays while moisturizing and reaffirming the skin (collagen, aloe vera, green tea).  Easy o apply for even, translucent coverage. Water resistant.

150ml. 5Fl.Oz.



Warning

TOPICAL USE / PROFESSIONAL ONLY

Instructions for use

Apply a considerable amount on entire body every day, with special emphasis on dry and damaged areas (legs, elbows, knees). Massage gently into the skin until completely absorbed

FMBODY
FIRMING AND MOISTURIZING  BODY
octinoxate emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42248-132
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE18.75 mL  in 250 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PEG-8 STEARATE (UNII: 2P9L47VI5E)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PEG-6 STEARATE (UNII: 8LQC57C6B0)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
SOYBEAN (UNII: L7HT8F1ZOD)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
CARBOMER HOMOPOLYMER TYPE B/C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
ALLANTOIN (UNII: 344S277G0Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ETHYLPARABEN (UNII: 14255EXE39)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
PEG-32 STEARATE (UNII: 33GX5WQC0M)  
EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
EDETIC ACID (UNII: 9G34HU7RV0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CUCUMBER (UNII: YY7C30VXJT)  
UREA (UNII: 8W8T17847W)  
ARNICA MONTANA (UNII: O80TY208ZW)  
IMIDUREA (UNII: M629807ATL)  
BOMBYX MORI FIBER (UNII: 6LK42KUV6W)  
FISH SKIN COLLAGEN, SOLUBLE (UNII: 8JC99XGU4W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42248-132-01250 mL in 1 BOTTLE
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: 5/2012
Document Id: a70fbcf1-c3e5-4653-a3c7-a3e29a190ac0
Set id: 7c457157-8a15-44bb-a292-b71cefa8ecfc
Version: 1
Effective Time: 20120523
 
Zenith Medicosm SL