Tinted Spf 45
FDA Label NDC 10477-2627

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Goodier Cosmetics, Lp for the product Tinted Spf 45 (NDC 10477-2627). 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 revision skincare 1.7oz retail intellishade®, otc - active ingredient, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, instructions for use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Revision Skincare 1.7Oz Retail Intellishade®

    Intellishade®
    SPF 45 Original

     anti-aging
     tinted moisturizer
     for all skin types


     NT WT 1.7 OZ / 48 G

Otc - Active Ingredient

    Active Ingredient   Purpose

     Octinoxate 7.5%        Sunscreen
     Octisalate 5%            Sunscreen
     Zinc Oxide 2%           Sunscreen

     Active Ingredient   Purpose

     Octinoxate 7.50%        Sunscreen
     Octisalate 5.00%         Sunscreen
     Zinc Oxide 2.00%        Sunscreen

    Active Ingredients:

    Octinoxate 7.5%, Octisalate 5.0%, Zinc Oxide 2.0%

Indications & Usage

    Uses
  • helps prevent sunburn
  • higher SPF gives more sun protection
  • for skin highly sensitive to sunburn
  •     Uses

    • Helps prevent sunburn.
    • Higher SPF gives more sun protection.
    • For skin highly sensitive to sunburn.

Warnings

    Warnings

    for external use only

    Warnings

    For external use only.

Otc - When Using

    When using this product

  • keep out of eyes, rinse with water to remove.
  •     When using this product

    • Keep out of eyes. Rinse with water to remove.

Otc - Stop Use

    Stop use and ask a doctor if
  • rash or irritation develops and lasts.
  •     Stop use and ask a doctor if

    • Rash or irritation develops and lasts.

Otc - Keep Out Of Reach Of Children

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

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

Instructions For Use

Directions
  • apply evenly before sun exposure and as needed.
  •     Directions

    • Apply evenly before sun exposure and as needed.
    • Children under 6 months of age: ask a doctor.
    • Reapply as needed or after towel drying, swimming or perspiring.

Other Safety Information

    Other Information
    High sun protection product

    Other Information
    High sun protection product.

Inactive Ingredient

Inactive ingredients    Water (Aqua), Cyclopentasiloxane, Ethylhexyl Stearate, Sorbitol,    Caprylic/Capric Triglyceride, Glycerin, Polyglyceryl-4 Isostearate,    Cetyl PEG/PPG 10/1 Dimethicone, Hexyl Laurate, Aloe Barbadensis    Leaf Juice, Cetyl Dimethicone, Betula Alba (White Birch) Extract,    Camellia Sinensis (Green Tea) Leaf Extract, Plankton Extract,    Beeswax, Dimethicone, Squalane, Tocopheryl Acetate, Tetrahexyldecyl    Ascorbate, Hydrogenated Castor Oil, Lecithin, Butylene Glycol, Caprylyl    Glycol, Palmitoyl Tripeptide-5, Saccharomyces Cerevisiae Extract,    Ubiquinone, Retinyl Palmitate, Sodium Chloride, Phenoxyethanol,    Chlorphenesin, Triethoxycaprylylsilane, Benzoic Acid, Sorbic Acid,    Titanium Dioxide, Iron Oxides

   Inactive ingredients
    Water (Aqua), Cyclopentasiloxane, Ethylhexyl Stearate, Sorbitol,
    Caprylic/Capric Triglyceride, Glycerin, Polyglyceryl-4 Isostearate,
    Cetyl PEG/PPG 10/1 Dimethicone, Hexyl Laurate, Aloe Barbadensis
    Leaf Juice, Cetyl Dimethicone, Betula Alba (White Birch) Extract,
    Camellia Sinensis (Green Tea) Leaf Extract, Plankton Extract,
    Beeswax, Dimethicone, Squalane, Tocopheryl Acetate, Tetrahexyldecyl
    Ascorbate, Hydrogenated Castor Oil, Lecithin, Butylene Glycol, Caprylyl
    Glycol, Palmitoyl Tripeptide-5, Saccharomyces Cerevisiae Extract,
    Ubiquinone, Retinyl Palmitate, Sodium Chloride, Phenoxyethanol,
    Chlorphenesin, Triethoxycaprylylsilane, Benzoic Acid, Sorbic Acid,
    Titanium Dioxide, Iron Oxides

Other

Dist. by Revision, Inc.    Dallas, TX 75247 Made in U.S.A.

Made in the USA

Distributed by Revercel, LLC
Cambell, CA 95008

     Skin Type:

    Suitable for all skin types to even out skin tone
    and protect against sunburn after procedures
    such as laser therapy, microdermabrasion and
    chemical peels.

    Key Ingredients and Benefits:

  • Broad spectrum sunscreens protect against UVA and UVB damage
  • Coenzyme Q10 and standardized Green Tea Extract provide antioxidant benefits
  • Natural minerals even out skin tone and conceal redness
  • THD Ascorbate (Vitamin C) and Palmitoyl Tripeptide-5 help reduce the appearance of fine lines and wrinkles
  •    

        Directions:

         Apply liberally to face and neck to help protect skin and conceal redness.


        Professional size only. Not for resale.

        Dist. by Revision, Inc
        Dallas, TX 75247 Made in U.S.A.

Revercel 1.7Oz Retail Triple Duty Sunscreen

Triple duty    sunscreen    spf 45    sheer tint    net. wt. 1.7oz / 48g

Revision Skincare 8Oz Professional Intellishade®

Intellishade®
SPF 45 Original

tinted moisturizer
for all skin types


NT WT 8 OZ / 227 G

Package Label.Principal Display Panel






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