DD TZ FORTE- titanium dioxide, zinc oxide, octinoxate, octisalate lotion

DD TZ FORTE by

Drug Labeling and Warnings

DD TZ FORTE by is a Otc medication manufactured, distributed, or labeled by LINEX HEALTH & BEAUTY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

TITANIUM DIOXIDE 2%

ZINC OXIDE 8%

OCTINOXATE 7.5%

OCTISALATE 5%

PURPOSE

SUNSCREEN

USES

• HELPS PREVENT SUNBURN.
• IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTION), DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

WARNINGS

FOR EXTERNAL USE ONLY.

DO NOT USE ON DAMAGED OR BROKEN SKIN.

WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.

STOP USE AND ASK A DOCTOR IF RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

• APPLY LIBERALLY BEFORE SUN EXPOSURE.
• REAPPLY -
• AFTER 40 MINUTES OF SWIMMING
• AT LEAST EVERY 2 HOURS
• CHILDREN UNDER 6 MONTHS; ASK A DOCTOR.

OTHER INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DD TZ FORTE 
titanium dioxide, zinc oxide, octinoxate, octisalate lotion

Product 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)
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)
MICA (UNII: V8A1AW0880)
CETEARYL ISONONANOATE (UNII: P5O01U99NI)

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)

Registrant - LINEX HEALTH & BEAUTY (050219996)

Establishment
Name	Address	ID/FEI	Business Operations
FMK LABS, INC.		046383819	manufacture(69769-102)