Defy Time Protector Moisturizer Broad Spectrum Spf 15
FDA Label NDC 68828-201

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 Defy Time Protector Moisturizer Broad Spectrum Spf 15 (NDC 68828-201). 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

Octinoxate  7.5%                         Sunscreen

Zinc Oxide  3%                            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 product is swallowed, get medical help or contact a Poison Contol 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 of SPF 15 or higher and other sun protection measures including:

    •      limit time in the sun, especially from 10a.m - 2p.m.

         wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredient

Inactive Ingredients

Water/Aqua, Tridecyl Neopentanoate, Polyglyceryl-3 Methylglucose Distearate, Glyceryl Stearate, Dimethicone, Glycerin, Triticum Vulgare (Wheat) Germ Protein, Avena Sativa (Oat) Kernel Protein,Saccharide lsomerate, Polyacrylamide, C13-141soparaffin, Laureth-7, Panthenol, DMDM Hydantoin, Diazolidinyl Urea, Biosaccharide Gum-4, Lecithin,Tocopheryl Acetate, Caprylic/Capric Triglylceride, Ubiquinone, Diisopropyl Adipate, Alcohol, Chondrus Crispus (Carrageenan) Extract, Chlorella Vulgaris Extract, Phytosterol lsostearate, Allantoin, Retinyl Palmitate, Ascorbyl Methylsilanol Pectinate, Trisodium EDTA, PEG-4 Laurate, lodopropynyl Bulylcarbamate, Propylene Glycol, Camellia Sinensis Leal Extract, Glycine Soja (Soybean) Seed Extract, Ceramide 3, Smithsonite Extract

Package Label.Principal Display Panel

Jafra

time dynamics defy

Time protector Moisturizer broad spectrum SPF 15

50ml 1.7fl oz

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