Label: HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50 BEIGE- titanium dioxide, zinc oxide cream
- NDC Code(s): 67015-2036-0, 67015-2036-1
- Packager: Pierre Fabre USA Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 29, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Keep out of reach of children.
-
Directions for use
- Apply liberally/generously and evenly15 minutes before sun exposure.
- Reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours.
- Children under 6 months: Consult a health care practitioner.
- 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 skin protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats and sunglasses.
-
Inactive Ingredients
DIMETHICONE, HYDROGENATED POLYISOBUTENE, PHENYL TRIMETHICONE, ISODECYL NEOPENTANOATE, SQUALANE, TALC, ETHYLHEXYL HYDROXYSTEARATE, POLYETHYLENE, POLYMETHYL METHACRYLATE, SILICA, WATER/EAU, POLYGLYCERLYL-3 DIISOSTEARATE, ALUMINA, STEARIC ACID, BEESWAX, BHT, CAPRYLIC/CAPRIC TRIGLYCERIDE, MICROCRYSTALLINE WAX, PHENOXYETHANOL, TOCOPHEROL, TOCOPHERYL GLUCOSIDE, TRIBEHENIN, TRIETHOXYCAPRYLYLSILANE, TITANIUM DIOXIDE (CI77891), IRON OXIDES (CI77492), (CI77491), (CI77499)
- Other Information
- HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 BEIGE 10g (67015-2036-0)
-
INGREDIENTS AND APPEARANCE
HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50 BEIGE
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67015-2036 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 4.9 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 13.7 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXYHYDROXIDE (UNII: 87PZU03K0K) HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ) FERRIC OXIDE RED (UNII: 1K09F3G675) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TRIBEHENIN (UNII: 8OC9U7TQZ0) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) ALUMINUM OXIDE (UNII: LMI26O6933) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) SQUALANE (UNII: GW89575KF9) TOCOPHEROL (UNII: R0ZB2556P8) PHENOXYETHANOL (UNII: HIE492ZZ3T) YELLOW WAX (UNII: 2ZA36H0S2V) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) TALC (UNII: 7SEV7J4R1U) ISODECYL NEOPENTANOATE (UNII: W60VYE24XC) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DIMETHICONE (UNII: 92RU3N3Y1O) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67015-2036-1 1 in 1 CARTON 03/15/2019 1 NDC:67015-2036-0 10 g in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/15/2019 Labeler - Pierre Fabre USA Inc. (117196928) Registrant - Pierre Fabre USA Inc. (117196928)
