Otc - Active Ingredient
Avobenzone 3%..............Sunscreen
Homosalate 10%.............Sunscreen
Octisalate 5%..................Sunscreen
Octocrylene 10%.............Sunscreen
Jafra Sun Tinted Face Protector Sunscreen Broad Spectrum 50 Cream
FDA Label NDC 68828-293
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Distribuidora Comercial Jafra, S.a. De C.v. for the product Jafra Sun Tinted Face Protector Sunscreen Broad Spectrum 50 (NDC 68828-293). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
Otc - 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.
Indications & Usage
Stop use and ask a doctor if rash occurs.
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.
Dosage & Administration
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if swimming or sweating
- reapply at least every 2 hours
- children under 6 months: Ask a doctor
- 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 value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredient
Acrylates/Ammonium Methacrylate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Bisabolol, Cellulose Acetate, Cetyl Alcohol, Dicaprylyl Carbonate, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Iron Oxides/CI 77491/CI 77492/CI 77499, Magnesium Stearate, Propylene Glycol Stearate, Panthenol, PEG-100 Stearate, Phenoxyethanol, Polyester-8, Sambucus Nigra (Elderberry) Fruit Extract, Styrene/Acrylates Copolymer, Titanium Dioxide (CI 77891 ), Tocopheryl Acetate, VP/Eicosene Copolymer, Water/Aqua
Other Safety Information
Protect this product from excessive heat and direct sun
Package Label.Principal Display Panel
JAFRA
SUN
50+
tinted face protector suncreen broad spectrum SPF 50+
Water Resistant (40 minutes)
50 ml e 1.7 FL OZ (US)
Sun Tinted Face Protector Spf 50 (Sunn Uctintedfaceprotectspf50)
* Please review the disclaimer below.
