Otc - Active Ingredient
Active Ingredients Purpose
Avobenzone 3% Sunscreen
Homosalate 10% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Oxybenzone 5% Sunscreen
Sunscreen Broad Spectrum Spf 50
FDA Label NDC 68828-165
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jafra Cosmetics International for the product Sunscreen Broad Spectrum Spf 50 (NDC 68828-165). 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, package label.principal display panel, 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 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 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
reapply at least ever 2 hours, especially if swimming, sweating, or after toweling
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 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-sleeve shirts, pants, hats, and sunglasses
Inactive Ingredient
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Acrylates/Octylacrylamide Copolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Bisabolol, Chlorphenesin, Cyclopentasiloxane, Disodium EDTA, Ethylhexylglycerin, Fragrance/parfum, Glyceryl Stearate, Lauroyl Lysine, Methylisothiazolinone, Mica, Silica, Panthenol, PEG-100 Stearate, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Water/Aqua.
Package Label.Principal Display Panel
Carton Back (Back)
Carton Front (Front)
Jafra Sun
50+
Sunscreen Cream Broad Spectrum SPF 50+
UVA/UVB Protection
125 ml 4.2 Fl Oz. (US)
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