Jafra Royal Jelly Revitalize
FDA Label NDC 68828-500

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 Jafra Royal Jelly Revitalize (NDC 68828-500). 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%.........................................................Sunscreen
Octisalate 5%..............................................................Sunscreen
Octocrylene 7%...........................................................Sunscreen

Otc - Purpose

Uses

  • helps prevent sunburn
    • if used as directed with other sunprotection 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 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 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 AcrylateCrosspolymer, Acrylates/Dimethicone Copolymer, Actinidia Chinensis(Kiwi) Fruit Water, Alcohol,Allantoin, Aluminum Starch Octenylsuccinate, Arachidy lAlcohol, 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/Acrylates Copolymer, Tetrapeptide-45,Water/Aqua

Package Label.Principal Display Panel

Jafra Royal

Royal Jelly

Revitalize

1 Gentle Cleansing Milk
30 ml 1 FL OZ (US)
1 Longevity Crème
14 ml 0.47 FL OZ (US)
1 Spot Serum
7,5 ml .25 FL OZ (US)
1 Solar Protection Fluid Broad Spectrum SPF 50
14 ml 0.47 FL OZ (US)
Contains: 4 Sample
Total Content 65,5 ml 2.21 FL OZ (US)

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