Label: HYDROMARINE EXTREME- octinoxate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 42248-101-02 - 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 January 21, 2012
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- Description
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INGREDIENTS AND APPEARANCE
HYDROMARINE EXTREME
octinoxate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42248-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3.75 mL in 50 mL Inactive Ingredients Ingredient Name Strength ALOE (UNII: V5VD430YW9) PROPYLPARABEN (UNII: Z8IX2SC1OH) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERIN (UNII: PDC6A3C0OX) TRICHLOROETHANE (UNII: 113C650IR1) SODIUM LAURYL SULFATE (UNII: 368GB5141J) WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PEG-8 STEARATE (UNII: 2P9L47VI5E) DIMETHICONE (UNII: 92RU3N3Y1O) SOYBEAN (UNII: L7HT8F1ZOD) CHONDRUS CRISPUS (UNII: OQS23HUA1X) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PROPYLPARABEN (UNII: Z8IX2SC1OH) BRONOPOL (UNII: 6PU1E16C9W) HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLPARABEN (UNII: A2I8C7HI9T) COLLAGEN, SOLUBLE, FISH SKIN (UNII: 8JC99XGU4W) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42248-101-02 1 in 1 BOX 1 50 mL in 1 JAR 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)