Label: DD TZ FORTE- titanium dioxide, zinc oxide, octinoxate, octisalate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 69769-102-11, 69769-102-51 - Packager: LINEX HEALTH & BEAUTY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 29, 2022
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- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
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INACTIVE INGREDIENTS
WATER, CYCLOPENTASILOXANE, GLYCERIN, PEG-10 DIMETHICONE, DIMETHICONE, POLYMETHYL METHACRYLATE, CETEARYL ISONONANOATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ACRYLATES/DIMETHICONE COPOLYMER, METHYL METHACRYLATE CROSSPOLYMER, SODIUM CHLORIDE, POLYGLYCERYL-3 POLYRICINOLEATE, GINKGO BILOBA LEAF EXTRACT, JOJOBA ESTERS, ALOE BARBADENSIS LEAF JUICE, PHENOXYETHANOL, DISTEARDIMONIUM HECTORITE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, BUTYLENE GLYCOL, SORBITAN SESQUIOLEATE, ALUMINUM HYDROXIDE, STEARIC ACID, CETYL RICINOLEATE, CAPRYLYL GLYCOL, TRIETHOXYCAPRYLYLSILANE, ETHYLHEXYLGLYCERIN, GLYCERYL CAPRATE, MAGNESIUM STEARATE, ALUMINUM TRISTEARATE, SILICA SILYLATE, HEXYLENE GLYCOL, TOCOPHEROL, BEESWAX, VINYL DIMETHICONE/METHICONE SESQUIOXANE CROSSPOLYMER, LYCIUM BARBARUM FRUIT EXTRACT, FRAGRANCE. MAY CONTAIN: MICA, IRON OXIDES (CI 77491, CI 77492, CI 77499)
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INGREDIENTS AND APPEARANCE
DD TZ FORTE
titanium dioxide, zinc oxide, octinoxate, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69769-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERIN (UNII: PDC6A3C0OX) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DIMETHICONE 100 (UNII: RO266O364U) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) METHYL METHACRYLATE (UNII: 196OC77688) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) GINKGO BILOBA WHOLE (UNII: 660486U6OI) MICA (UNII: V8A1AW0880) CETEARYL ISONONANOATE (UNII: P5O01U99NI) ALOE VERA LEAF (UNII: ZY81Z83H0X) PHENOXYETHANOL (UNII: HIE492ZZ3T) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) LICORICE (UNII: 61ZBX54883) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) CETYL RICINOLEATE (UNII: 1P677500YD) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERYL CAPRATE (UNII: 197M6VFC1W) MAGNESIUM STEARATE (UNII: 70097M6I30) ALUMINUM STEARATES (UNII: O4D7U3B46U) SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W) HEXYLENE GLYCOL (UNII: KEH0A3F75J) TOCOPHEROL (UNII: R0ZB2556P8) YELLOW WAX (UNII: 2ZA36H0S2V) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK) LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69769-102-51 1 in 1 BOX 04/29/2015 1 NDC:69769-102-11 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/29/2015 Labeler - LINEX HEALTH & BEAUTY (050219996)