FDA Label for Solar Protection Fluid Broad Spectrum Spf 50

View Indications, Usage & Precautions

Solar Protection Fluid Broad Spectrum Spf 50 Product Label

The following document was submitted to the FDA by the labeler of this product Jafra Cosmetics International. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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