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

HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50 by

Drug Labeling and Warnings

HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50 by is a Otc medication manufactured, distributed, or labeled by Pierre Fabre USA Inc., Pierre Fabre USA Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

TITANIUM DIOXIDE 14.2 %
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 evenly 15 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 sun protection measures including:
  • limit time in the sun, especially from 10 a.m. to 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. POLYGLYCERLYL-3 DIISOSTEARATE. ALUMINA. WATER. STEARIC ACID. BEESWAX. BHT. CAPRYLIC/CAPRIC TRIGLYCERIDE. MICROCRYSTALLINE WAX. PHENOXYETHANOL. TOCOPHEROL. TOCOPHERYL GLUCOSIDE. TRIBEHENIN. TRIETHOXYCAPRYLYLSILANE. TITANIUM DIOXIDE. IRON OXIDES.

Other information

• Protect this product from excessive heat and direct sun
  

QUESTIONS

Questions ?

1-866-41-AVENE

(28363) (USA)

1-877-441-2011 (CAN)

PACKAGE LABEL - HIGH PROTECTION TINTED COMPACT BEIGE

HAUTE PROTECTION

HIGH PROTECTION

COMPACT TEINTÉ – TINTED COMPACT

SABLE

BEIGE

RÉSISTANT À L’EAU

WATER RESISTANT

40 minutes

UVB UVA

FPS
SPF

LARGE SPECTRE

BROAD SPECTRUM

50

Peaux intolérantes – For intolerant skin

NON COMÉDOGÉNE – N’OBSTRUE PAS LES PORES

LABORATOIRES DERMATOLOGIQUES AVÈNE – PARIS

10g e    NET WT. 0.3 OZ.

PACKAGE LABEL - HIGH PROTECTION TINTED COMPACT HONEY

HAUTE PROTECTION

HIGH PROTECTION

COMPACT TEINTÉ – TINTED COMPACT

DORÉ

HONEY

RÉSISTANT À L’EAU

WATER RESISTANT

40 minutes

UVB UVA

FPS
SPF

LARGE SPECTRE

BROAD SPECTRUM

50

Peaux intolérantes – For intolerant skin

NON COMÉDOGÉNE – N’OBSTRUE PAS LES PORES

LABORATOIRES DERMATOLOGIQUES AVÈNE – PARIS

10g e    NET WT. 0.3 OZ.

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67015-1002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.42 g  in 10 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.49 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
SQUALANE (UNII: GW89575KF9)
TALC (UNII: 7SEV7J4R1U)
ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
ALUMINUM OXIDE (UNII: LMI26O6933)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERROUS OXIDE (UNII: G7036X8B5H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67015-1002-2	1 in 1 CARTON	06/01/2017	03/31/2021
1		10 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 67015-1002-4	1 in 1 CARTON	06/01/2017	12/31/2020
2		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	06/01/2017	03/31/2021

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc (117196928)