Your browser does not support JavaScript! TOO FACED TINTED BEAUTY BALM SPF-20 (TITANIUM DIOXIDE ZINC OXIDE) CREAM [TOO FACED COSMETICS]
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TOO FACED TINTED BEAUTY BALM SPF-20 (titanium dioxide zinc oxide) cream
[TOO FACED COSMETICS]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Sections

ACTIVE INGREDIENTS

TITANIUM DIOXIDE 5.0%

ZINC OXIDE 5.0%

PURPOSE

SUNSCREEN

USE

  • HELPS PREVENT SUNBURN

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE ON DAMAGED OR BROKEN SKIN.

STOP USE AND ASK DOCTOR IF RASH OCCURS.

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

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

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 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 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?

(949) 553-4431

MON-FRI 9AM-5PM (PST)

TF Beauty Balm SPF-20 Tube Artwork US (12-2012)

TF Beauty Balm SPF-20 Unit Carton Artwork US (12-2012)

TOO FACED TINTED BEAUTY BALM  SPF-20
titanium dioxide zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:79596-090
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE5 g  in 100 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
CYCLOMETHICONE 5 
PROPYLENE GLYCOL 
OCTYLDODECYL NEOPENTANOATE 
PEG/PPG-18/18 DIMETHICONE 
DIMETHICONE 
CYCLOMETHICONE 6 
MAGNESIUM CHLORIDE 
POTASSIUM CHLORIDE 
SODIUM CHLORIDE 
ZINC CHLORIDE 
LYSINE 
PANAX GINSENG ROOT WATER 
GINKGO BILOBA WHOLE 
CHAMAEMELUM NOBILE FLOWER 
CAMELLIA OLEIFERA LEAF 
PHYTANTRIOL 
MAGNESIUM ASCORBYL PHOSPHATE 
VITAMIN A PALMITATE 
.ALPHA.-TOCOPHEROL ACETATE 
TOCOPHEROL 
TETRAHEXYLDECYL ASCORBATE 
ALUMINUM HYDROXIDE 
STEARIC ACID 
TRIETHOXYCAPRYLYLSILANE 
BORON NITRIDE 
GLYCERIN 
SODIUM DEHYDROACETATE 
PALMITIC ACID 
ICODEXTRIN 
HYALURONATE SODIUM 
BUTYLENE GLYCOL 
PHENOXYETHANOL 
METHYLPARABEN 
PROPYLPARABEN 
MICA 
BROWN IRON OXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79596-090-221 in 1 BOX
1NDC:79596-090-2145 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/14/2012
Labeler - TOO FACED COSMETICS (014131481)

Revised: 1/2013
 
TOO FACED COSMETICS

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