Active Ingredients
TITANIUM DIOXIDE 13.7 %
ZINC OXIDE 4.9 %
Haute Protection High Protection Tinted Compact Broad Spectrum Spf 50 Honey Cream
FDA Label NDC 67015-2035
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pierre Fabre Usa Inc. for the product Haute Protection High Protection Tinted Compact Broad Spectrum Spf 50 Honey (NDC 67015-2035). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, keep out of reach of children., directions for use, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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