Solar Protection Fluid Broad Spectrum Spf 50
FDA Label NDC 68828-282

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 Solar Protection Fluid Broad Spectrum Spf 50 (NDC 68828-282). 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 - Active Ingredient

Active Ingredients        Purpose

Avobenzone 3%         Sunscreen

Homosalate 10%        Suncreen

Octisalate 5%            Suncreen

Octocrylene 7%         Sunscreen

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 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
  • reapply at least every 2 hours children under 6 months: Ask a doctor
  • Sun Protection Measures. Spending time in the sun icreases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Specturm SPF 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

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Actinidia Chinensis (Kiwi) Fruit Water, Alcohol, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Benzyl Alcohol, Bisabolol,
Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Chlorphenesin, Cocos Nucifera Fruit Extract, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Hydrogenated Lecithin, Lauroyl Lysine, Lecithin, Maltodextrin, Moringa Oleifera Leaf Extract, PEG-100 Stearate, Phenethyl Alcohol, Polygonum Aviculare Extract, Royal Jelly, Sodium Ascorbyl Phosphate, Sophora Flavescens Root Extract, Styrene/Acrylate Copolymer, Tetrapeptide-45, Water/Aqua

Package Label.Principal Display Panel

JAFRA

Royal Jelly

Solar Protection Fluid

Broad Spectrum SPF 50

50 ml   1.7 FL OZ (US)

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