SPL v1
SPL
SPL Set ID 6b68c45a-8685-4166-8628-2d304048251c
Route
TOPICAL
Published
Effective Date 2011-12-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Octisalate (5 g) Zinc Oxide (2 g)
Inactive Ingredients
Water Cyclomethicone 5 Ethylhexyl Stearate Sorbitol Medium-chain Triglycerides Glycerin Polyglyceryl-4 Isostearate Cetyl Peg/ppg-10/1 Dimethicone (hlb 1.5) Hexyl Laurate Aloe Vera Leaf Betula Pubescens Bark Green Tea Leaf White Wax Dimethicone Squalane .alpha.-tocopherol Acetate, D- Tetrahexyldecyl Ascorbate Hydrogenated Castor Oil Lecithin, Soybean Butylene Glycol Caprylyl Glycol Palmitoyl Tripeptide-5 Ubidecarenone Vitamin A Palmitate Phenoxyethanol Chlorphenesin Triethoxycaprylylsilane Benzoic Acid Sorbic Acid Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2007-12-01

Description

    Intellishade®     SPF 45 Original      anti-aging      tinted moisturizer      for all skin types      NT WT 1.7 OZ / 48 G


Medication Information

Warnings and Precautions

    Warnings

    for external use only

Indications and Usage
    Uses

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

Description

    Intellishade®     SPF 45 Original      anti-aging      tinted moisturizer      for all skin types      NT WT 1.7 OZ / 48 G

Section 42229-5


    Dist. by Revision, Inc.

    Dallas, TX 75247 Made in U.S.A.

Section 50565-1

    Keep this and all drugs out of reach

    of children.
  If swallowed, get medical

    help or contact a Poison Control

    Center right away.

Section 50566-9
    Stop use and ask a doctor if
  • rash or irritation develops and lasts.

Section 50567-7

    When using this product

  • keep out of eyes, rinse with water to remove.

Section 51727-6
   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

Section 51945-4










Section 55106-9

    Active Ingredient   Purpose

     Octinoxate 7.5%        Sunscreen

     Octisalate 5%            Sunscreen

     Zinc Oxide 2%           Sunscreen

Section 59845-8
    Directions

  • apply evenly before sun exposure and as needed.

Section 60561-8

    Other Information

    High sun protection product

Revercel 1.7oz Retail Triple Duty Sunscreen
    triple duty

    sunscreen




    spf 45

    sheer tint





    net. wt. 1.7oz / 48g

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

Revision Skincare 8oz Professional Intellishade®

Intellishade®

SPF 45 Original



tinted moisturizer

for all skin types





NT WT 8 OZ / 227 G


Structured Label Content

Indications and Usage (34067-9)
    Uses

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

Warnings and Precautions (34071-1)

    Warnings

    for external use only

Section 42229-5 (42229-5)


    Dist. by Revision, Inc.

    Dallas, TX 75247 Made in U.S.A.

Section 50565-1 (50565-1)

    Keep this and all drugs out of reach

    of children.
  If swallowed, get medical

    help or contact a Poison Control

    Center right away.

Section 50566-9 (50566-9)
    Stop use and ask a doctor if
  • rash or irritation develops and lasts.

Section 50567-7 (50567-7)

    When using this product

  • keep out of eyes, rinse with water to remove.

Section 51727-6 (51727-6)
   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

Section 51945-4 (51945-4)










Section 55106-9 (55106-9)

    Active Ingredient   Purpose

     Octinoxate 7.5%        Sunscreen

     Octisalate 5%            Sunscreen

     Zinc Oxide 2%           Sunscreen

Section 59845-8 (59845-8)
    Directions

  • apply evenly before sun exposure and as needed.

Section 60561-8 (60561-8)

    Other Information

    High sun protection product

Revercel 1.7oz Retail Triple Duty Sunscreen
    triple duty

    sunscreen




    spf 45

    sheer tint





    net. wt. 1.7oz / 48g

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

Revision Skincare 8oz Professional Intellishade®

Intellishade®

SPF 45 Original



tinted moisturizer

for all skin types





NT WT 8 OZ / 227 G


Advanced Ingredient Data


Raw Label Data

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