Label: FIRMING AND MOISTURIZING BODY- octinoxate emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 42248-132-01 - Packager: Zenith Medicosm SL
- 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 May 23, 2012
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- Official Label (Printer Friendly)
- Active Ingredient
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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
- Instructions for use
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FIRMING AND MOISTURIZING BODY
octinoxate emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42248-132 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 18.75 mL in 250 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:42248-132-01 250 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/15/2011 Labeler - Zenith Medicosm SL (464239694) Registrant - Zenith Medicosm SL (464239694) Establishment Name Address ID/FEI Business Operations Zenith Medicosm SL 464239694 manufacture