Sable Long Wear Makeup
FDA Label NDC 68828-337

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 Sable Long Wear Makeup (NDC 68828-337). 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

Octisalate 3% ...... Sunscreen

Zinc Oxide 6.82% .... Sunscree

Otc - Purpose

Uses

  • helps prevent suburn
  • 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 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 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

Water/Aqua, Triethoxycaprylylsilane, Caprylic Capric Triglyceride, Polyhydroxystearic Acid, Cyclomethicone, Hydroxypropylcocoate PEG-8 Dimethicone, Phenyl Triemthicone, C12-15 Alkyl Benzoate, Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Phenyl Dimethicone, Di-PPG-3 Myristyl Ether Adipate, Caprylyl Methicone, Dimethicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Propanediol, Sodium Chloride, Squalane, Boron Nitride, Synthetic Fluorophlogopite, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Dextrin Palmitate, Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Anuus (Sunflower) Extract, Tocopherol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Sodium Hyaluronate, Butylene Glycol, Glycyrrhiza Glabra (Licorice) Extract, Benzimidazole Diamond Amidoethyl Urea Carbamoyl Propyl Polymehtylsilsesquioxane, Lentinus Edodes (shiitake) Extract, Ipomoea Batatas Tuber Extract, Centella Asiatica Extract, Withania Somniferia Extract, Butylene Glycol, Biosaccharide Gum-4, Smithsonite Extact, Chondrus Crispus (Carrageenan) Extract [ May Containt +/-: Titanium Dioxide, Iron Oxides/ CI 77492/ CI 77491/ CI 77499]

Package Label.Principal Display Panel

JAFRA

Long Wear Makeup

Broad Spectrum SPF 20

30 ml / 1 FL oz (us)

Label (Colr 117uclongwearmkupspf20usa)

Label (Colr 117uclongwearmkupspf20usa)

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