Label: UNISEX BB TINT- IT S CLEAR - 6552- titanium dioxide cream
-
Contains inactivated NDC Code(s)
NDC Code(s): 82063-6552-0 - Packager: Faberlic Joint Stock Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 26, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Uses
- Warnings
-
Directions
- Apply liberally 15 minutes before sun exposure
- Children undre 6 months of age: Ask a doctor
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Sun protection measures.
- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, reguarly use a sunscreen with a Broad Spectrum SPF value 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
-
Inactive ingredients
Aqua/Water, Coco-Caprylate*, Dicaprylyl Carbonate*, Shea Butter Ethyl Ester*, C15-19 Alkane*, Glycerin*, Magnesium Stearate*, Polyglyceryl-6 Polyhydroxystearate*, Polyglyceryl-6 Polyricinoleate*, Silica*, Jojoba Esters*, Persea Gratissima (Avocado) Oil*, Hydrogenated Vegetable Oil*, Sodium Chloride*, Glyceryl Behenate*, Magnesium Sulfate*, Sodium Hyaluronate*, Panax Ginseng Root Extract**, CentellaAsiatica Extract**, Tocopherol*, Polyhydroxystearic Acid*, Phenoxyethanol, Ethylhexylglycerin, Sodium Benzoate, Potassium Sorbate, Parfum/Fragrance, Citric Acid, Iron Oxides Red*, Iron Oxides Black, Iron Oxides Yellow*.
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
UNISEX BB TINT- IT S CLEAR - 6552
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82063-6552 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 74.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCO-CAPRYLATE (UNII: 4828G836N6) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG) C15-19 ALKANE (UNII: CI87N1IM01) GLYCERIN (UNII: PDC6A3C0OX) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) AVOCADO OIL (UNII: 6VNO72PFC1) SODIUM CHLORIDE (UNII: 451W47IQ8X) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ASIAN GINSENG (UNII: CUQ3A77YXI) CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J) TOCOPHEROL (UNII: R0ZB2556P8) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SODIUM BENZOATE (UNII: OJ245FE5EU) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82063-6552-0 1 in 1 CARTON 01/11/2022 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/11/2022 Labeler - Faberlic Joint Stock Company (365955546)
