Label: SOFT DERM INTENSIVE DEFENSE 8 SPF- octinoxate, titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 75870-002-01, 75870-002-02 - Packager: LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA
- 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 June 15, 2011
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- DESCRIPTION
- INSTRUCTIONS FOR USE
- WARNINGS
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
OTHER INGREDIENTS: AQUA (THERMAL WATER), ICTYLDODECYL MYRISTATE, PEG-6 STEARATE, GLYCERIN, C12-15 ALKYL BENZOATE, CETYL ALCOHOL, DIMETHICONE, ALOE BARBADENSIS GEL 10:1, CAPPARIS SPINOSA FRUIT EXTRACT, HYDROLYZED ENTEROMORPHA COMPRESSA EXTRACT, CETETH-20, GLYCERYL STEARATE, STEARETH-20, XANTUAN GUM, ALLANTOIN, BUTYLENE GLYCOL, ALUMINUM STEARATE, POLYHYDROXYSTEARIC ACID, ALUMINUM OXIDE, DISODIUM EDTA, PHENOXYETANOL, METHYLPARABEN, BUTYLPARABEN, ETHYLPARABEN, PROPYLPARABEN, ISOBUTYLPARABEN, DIMENTICONE CROSSPOLYMER, BHT, PERFUM.
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INGREDIENTS AND APPEARANCE
SOFT DERM INTENSIVE DEFENSE 8 SPF
octinoxate, titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75870-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 10 mL in 50 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE 7.045 mL in 50 mL Inactive Ingredients Ingredient Name Strength OCTYLDODECYL MYRISTATE (UNII: S013N99GR8) PEG-6 STEARATE (UNII: 8LQC57C6B0) GLYCERIN (UNII: PDC6A3C0OX) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHICONE (UNII: 92RU3N3Y1O) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAPER BERRY (UNII: 7G4C45EE8C) CAPSOSIPHON FULVESCENS (UNII: C59NK6GFJH) CETETH-20 (UNII: I835H2IHHX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) STEARETH-20 (UNII: L0Q8IK9E08) XANTHAN GUM (UNII: TTV12P4NEE) ALLANTOIN (UNII: 344S277G0Z) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ALUMINUM STEARATE (UNII: U6XF9NP8HM) HYDROXYSTEARIC ACID (UNII: 933ANU3H2S) ALUMINUM OXIDE (UNII: LMI26O6933) EDETATE DISODIUM (UNII: 7FLD91C86K) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) BUTYLPARABEN (UNII: 3QPI1U3FV8) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) ISOBUTYLPARABEN (UNII: 0QQJ25X58G) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) WATER (UNII: 059QF0KO0R) ULVA COMPRESSA PROTEIN (ACID HYDROLYZED, 300-5000 MW) (UNII: Q04O53779D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75870-002-02 1 in 1 CARTON 1 NDC:75870-002-01 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 07/01/2007 Labeler - LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA (467582193) Establishment Name Address ID/FEI Business Operations LABORATORIOS DE COSMETICA SCIENTIFICA ATACHE SA 467582193 manufacture
