Jafra Royal Luna Bright Kit
FDA Label NDC 68828-757

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 Inc for the product Jafra Royal Luna Bright Kit (NDC 68828-757). 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 active ingredient(s), purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient(S)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%

Purpose

Sunscreen

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.

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

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.

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 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 measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Arginine, Benzyl Alcohol, Bisabolol, Butyrospermum Parkii (Shea) Butter, Butylene Glycol, Chlorphenesin, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lauroyl Lysine, Hydrogenated Lecithin, Lecithin, Maltodextrin, PEG-100 Stearate, Palmaria Palmata (red seaweed) Extract, Phenoxyethanol, Phenethyl Alcohol, Polysorbate 60, Royal Jelly, Royal Jelly Powder, Silica, Sorbitan Isostearate, Styrene/Acrylates Copolymer, Tetrapeptide-45, Theobroma Cacao (Cocoa) Seed Extract, Water/Aqua, Yeast Extract

Other Information

Protect this product from excessive heat and direct sun

Product Label

Image Description (Image 05)

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