TOO FACED TINTED BEAUTY BALM SPF-20- titanium dioxide zinc oxide cream

Too Faced Tinted Beauty Balm by

Drug Labeling and Warnings

Too Faced Tinted Beauty Balm by is a Otc medication manufactured, distributed, or labeled by TOO FACED COSMETICS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

TITANIUM DIOXIDE 5.0%

ZINC OXIDE 5.0%

PURPOSE

PURPOSE

SUNSCREEN

INDICATIONS & USAGE

USE

• HELPS PREVENT SUNBURN

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE

DO NOT USE ON DAMAGED OR BROKEN SKIN.

STOP USE

STOP USE AND ASK DOCTOR IF RASH OCCURS.

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

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

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

OTHER INFORMATION

• YOU MAY REPORT A SERIOUS ADVERSE REACTION TO:
  17361 ARMSTRONG AVENUE
  IRVINE, CA 92614
• PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT.

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

QUESTIONS?

(949) 553-4431

MON-FRI 9AM-5PM (PST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOO FACED TINTED BEAUTY BALM  SPF-20
titanium dioxide zinc oxide cream

Product 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)