Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 10% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Jafra Sun Sunscreen Broad Spectrum Spf 50 Spray
FDA Label NDC 68828-296
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 Sunscreen Broad Spectrum Spf 50 (NDC 68828-296). 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
Uses
- 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
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
Directions
- Apply liberally 15 minutes before sun exposure
- Use a water-resistant sunscreen if swimming or sweating
- Sun Protection Measures Spending time in the sun increases your risk of
Reapply at least every 2 hours.
•Children under 6 months of age: ask a doctor.
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 your time in the sun, especially from 10
a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredient
Inactive Ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Bisabolol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylyl Glycol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Ethylhexyl Methoxycrylene, Fragrance/Parfum, Glycerin, Hexylene Glycol, Phenoxyethanol, Polyester-5, Polyester-8, Polysorbate 20, Potassium Cetyl Phosphate, Sambucus Nigra (Elderberry) Fruit Extract, Sodium Silicoaluminate, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Triethanolamine, Water/Aqua
Other Safety Information
Other information
- protect this product from excessive heat and direct sun
Package Label.Principal Display Panel
Jafra Sun
Spray on Sunscreen Broad Spectrum SPF 50
WATER RESISTANT (40 MINUTES)
125 ml 4.2 FL OZ (US)
Sunn Spray 50 (Sunn 004ucsunonspray50usa)
* Please review the disclaimer below.
