Haute Protection High Protection Tinted Compact Broad Spectrum Spf 50 Honey

Haute Protection High Protection Tinted Compact Broad Spectrum Spf 50 Honey
SPL v4
SPL
SPL Set ID 8ab57a9b-db89-1bf2-e053-2995a90a303a
Route
TOPICAL
Published
Effective Date 2019-06-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (4.9 g) Titanium Dioxide (13.7 g)
Inactive Ingredients
Water Ferric Oxide Yellow Ferrosoferric Oxide Ferric Oxyhydroxide Hydrogenated Polybutene (1300 Mw) Ferric Oxide Red Medium-chain Triglycerides Butylated Hydroxytoluene Triethoxycaprylylsilane Tribehenin Microcrystalline Wax Aluminum Oxide Poly(methyl Methacrylate; 450000 Mw) Squalane Tocopherol Phenoxyethanol Yellow Wax Silicon Dioxide High Density Polyethylene Talc Isodecyl Neopentanoate Phenyl Trimethicone Dimethicone Polyglyceryl-3 Diisostearate Ethylhexyl Hydroxystearate Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-06-03
Description

TITANIUM DIOXIDE 13.7 % ZINC OXIDE 4.9 %

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

TITANIUM DIOXIDE 13.7 % ZINC OXIDE 4.9 %

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.

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients

TITANIUM DIOXIDE 13.7 %



ZINC OXIDE 4.9 %

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)

Keep Out of Reach of Children.

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

Haute Protection High Protection Tinted Compact Broad Spectrum Spf 50 Honey 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

Structured Label Content

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.
Purpose

Sunscreen

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.

Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients (Active ingredients)

TITANIUM DIOXIDE 13.7 %



ZINC OXIDE 4.9 %

Directions for Use (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)

Keep Out of Reach of Children. (Keep out of reach of children.)

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

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

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:45.219236 · Updated: 2026-03-14T23:02:27.804765