HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey

Manufacturer
Pierre Fabre USA Inc.
Effective date
2024-01-29
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:08:05

Label at a glance#

ProductHAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections

Indications and 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.

Dosage and administration

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 ...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

TITANIUM DIOXIDE 13.7 %

ZINC OXIDE 4.9 %

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions for use

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 HONEY 10g (67015-2035-0)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

HoneyHoney

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67015-2035-0HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey10 g in 1 CONTAINERCREAM104
67015-2035-1HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 Honey1 in 1 CARTONCREAM14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67015-2035HAUTE PROTECTION HIGH PROTECTION TINTED COMPACT BROAD SPECTRUM SPF 50 HONEY (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [PIERRE FABRE USA INC.]4Current NDC, Legacy NDC, 2 package rows20240131_8ab57a9b-db89-1bf2-e053-2995a90a303a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67015-203567015-2035-0, 67015-2035-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAUTE PROTECTION High Protection Tinted Compact Broad Spectrum SPF 50 HoneyTITANIUM DIOXIDE, ZINC OXIDEPierre Fabre USA Inc.8ab57a9b-db89-1bf2-e053-2995a90a303a2024-01-29WarningsExact identifier
ndc (package): 67015-2035-0
ndc (package): 67015-2035-1
ndc (product): 67015-2035
ndc11 (package): 67015203501
ndc11 (package): 67015203500
spl id: 101d8f73-f841-c0e0-e063-6294a90a7d91
spl set id: 8ab57a9b-db89-1bf2-e053-2995a90a303a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.