Label: TOO FACED TINTED BEAUTY BALM SPF-20- titanium dioxide zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 79596-090-21, 79596-090-22 - Packager: TOO FACED COSMETICS
- 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 January 8, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
DIRECTIONS
- APPLY LIBERALLY AND SMOOTHLY 15 MINUTES BEFORE SUN EXPOSURE.
- USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.
- REAPPLY AT LEAST EVERY 2 HOURS.
- CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.
- OPTIONAL: APPLY TO ALL SKIN EXPOSED TO THE SUN.
- SUN PROTECTION MEASURES. SPENDING TIME IN THE SUN INCREASES YOUR RISK OF SKIN CANCER AND EARLY SKIN AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD SPECTRUM SPF OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING:
- LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 A.M. - 2 P.M.
- WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES.
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS
WATER, CYCLOPENTASILOXANE, PROPYLENE GLYCOL, OCTYLDODECYL NEOPENTANOATE, PEG/PPG-18/18 DIMETHICONE, DIMETHICONE, CYCLOHEXASILOXANE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM CHLORIDE, ZINC CHLORIDE, LYSINE, PANAX GINSENG ROOT EXTRACT, GINKGO BILOBA LEAF EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, CAMELLIA OLEIFERA LEAF EXTRACT, PHYTANTRIOL, MAGNESIUM ASCORBYL PHOSPHATE, RETINYL PALMITATE, TOCOPHERYL ACETATE, TOCOPHEROL, TETRAHEXYDECYL ASCORBATE, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILOXANE, BORON NITRIDE, GLYCERIN, SODIUM DEHYDROACETATE, PALMITIC ACID, DEXTRIN PALMITATE, SODIUM HYALURONATE, BUTYLENE GLYCOL, PHENOXYETHANOL, METHYLPARABEN, PROPYLPARABEN, MICA, IRON OXIDES.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOO FACED TINTED BEAUTY BALM SPF-20
titanium dioxide zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79596-090 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 5 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DIMETHICONE (UNII: 92RU3N3Y1O) CYCLOMETHICONE 6 (UNII: XHK3U310BA) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) SODIUM CHLORIDE (UNII: 451W47IQ8X) ZINC CHLORIDE (UNII: 86Q357L16B) LYSINE (UNII: K3Z4F929H6) PANAX GINSENG ROOT WATER (UNII: P9T4K47OM0) GINKGO BILOBA WHOLE (UNII: 660486U6OI) CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) PHYTANTRIOL (UNII: 8LVI07A72W) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TOCOPHEROL (UNII: R0ZB2556P8) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) STEARIC ACID (UNII: 4ELV7Z65AP) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) BORON NITRIDE (UNII: 2U4T60A6YD) GLYCERIN (UNII: PDC6A3C0OX) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) PALMITIC ACID (UNII: 2V16EO95H1) ICODEXTRIN (UNII: 2NX48Z0A9G) HYALURONATE SODIUM (UNII: YSE9PPT4TH) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) MICA (UNII: V8A1AW0880) BROWN IRON OXIDE (UNII: 1N032N7MFO) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79596-090-22 1 in 1 BOX 1 NDC:79596-090-21 45 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/14/2012 Labeler - TOO FACED COSMETICS (014131481)