HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50 HONEY- titanium dioxide, zinc oxide cream

HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey by

Drug Labeling and Warnings

HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey by is a Otc medication manufactured, distributed, or labeled by Pierre Fabre USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

TITANIUM DIOXIDE 13.7 %

ZINC OXIDE 4.9 %

Purpose

Sunscreen

Uses

• Tinted compact SPF 50 helps prevent sunburn.
• If used as directed with other sun protection measures ( see Directions for use), decreases the risk if skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Do not use on damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and consult a health care practitioner if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

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 (CI77491), (CI77492), (CI77499)

Other Information

Protect this product from excessive heat and direct sun.

HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 BEIGE 10g (

67015-2035-0)

HAUTE

PROTECTION

HIGH PROTECTION

Fragrance-free

SPF 50 UVB UVA Broad spectrum

Water-resistant

40 minutes

Honey

Tinted compact

For intolerant skin

PARIS

10g e/NET WT. 0.3 OZ.- NPN 80085664

INGREDIENTS AND APPEARANCE

HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50 HONEY 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67015-2035
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: 67015-2035-1	1 in 1 CARTON	06/03/2019
1	NDC: 67015-2035-0	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 not final	part352	06/03/2019

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)