Jafra Sun Body Sunscreen Broad Spectrum Spf 50 Water Resistant 40 Minutes Cream
FDA Label NDC 68828-330

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Distribuidora Comercial Jafra, S.a. De C.v. for the product Jafra Sun Body Sunscreen Broad Spectrum Spf 50 Water Resistant 40 Minutes (NDC 68828-330). 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 ingredients                            purpose, uses, warnings, directions, other information, inactive ingredients, questions?, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients                            Purpose

Avobenzone 3%                               Sunscreen
Homosalate 10%                              Sunscreen
Octisalate 5%                                   Sunscreen
Octocrylene 10%                              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 useon damaged or broken skin

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

Stop use and ask a doctor ifrash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally and evenly 15 minutes before sun exposure
  • reapply :

    • •after 40 minutes of swimming or sweating

    •immediately after towel drying

    •at least every 2 hours

    • children under 6 months of age: 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-sleeved shirts, pants, hats, and sunglasses

Other Information

  • protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Polyester-8, Styrene/Acrylates Copolymer, Cetyl Alcohol, Dicaprylyl Carbonate, VP/Eicosene Copolymer, Glyceryl Stearate, PEG-100 Stearate, Ethylhexyl Methoxycrylene, Phenoxyethanol, Mica, Arginine, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Fragrance, Ethylhexylglycerin, Disodium EDTA, Panthenol, Bisabolol, Benzyl Salicylate, Silica, Coumarin, Benzyl Benzoate, Linalool, Hydroxycitronellal, Sambucus Nigra Fruit Extract

Questions?

Call 1-800-551-2345 or visit www.jafra.com

Product Label

Image Description (Image 330)

Image Description (Image 330)

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