HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50: Package Insert and Label Information

HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide cream
Tecnocosmesi S.p.A.

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 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 ?

1-866-41-AVENE

(28363) (USA)

1-877-441-2011 (CAN)

PACKAGE LABEL — HIGH PROTECTION TINTED COMPACT HONEY

HAUTE PROTECTION

HIGH PROTECTION

COMPACT TEINTÉ – TINTED COMPACT

DORE — HONEY and 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.

NPN 80085664

NPN 80085668

Label
(click image for full-size original)
Label 1
(click image for full-size original)

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:66888-051
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 1.42 g in 10 g
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 0.49 g in 10 g
Inactive Ingredients
Ingredient Name Strength
PHENOXYETHANOL
TOCOPHEROL
.ALPHA.-TOCOPHEROL ACETATE
TRIBEHENIN
TRIETHOXYCAPRYLYLSILANE
FERROUS OXIDE
POLY(METHYL METHACRYLATE; 450000 MW)
SILICON DIOXIDE
POLYGLYCERYL-3 DIISOSTEARATE
ALUMINUM OXIDE
WATER
STEARIC ACID
YELLOW WAX
BUTYLATED HYDROXYTOLUENE
MEDIUM-CHAIN TRIGLYCERIDES
DIMETHICONE
HYDROGENATED POLYBUTENE (1300 MW)
PHENYL TRIMETHICONE
ISODECYL NEOPENTANOATE
SQUALANE
TALC
ETHYLHEXYL HYDROXYSTEARATE
HIGH DENSITY POLYETHYLENE
MICROCRYSTALLINE WAX
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66888-051-01 1 CONTAINER in 1 CARTON contains a CONTAINER
1 10 g in 1 CONTAINER This package is contained within the CARTON (66888-051-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/16/2021
Labeler — Tecnocosmesi S.p.A. (435445218)
Registrant — Tecnocosmesi S.p.A. (435445218)
Establishment
Name Address ID/FEI Operations
Tecnocosmesi S.p.A. 435445218 manufacture (66888-051)

Revised: 09/2022 Tecnocosmesi S.p.A.

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