1.7Oz Revision Intellishade® Original
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The following Structured Product Label (SPL) was submitted to the FDA by Revision, Llc for the product Intellishade Truphysical Clear Spf 50 (NDC 64651-1226). 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 1.7oz revision intellishade® original, other, otc - active ingredient, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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Intellishade®
Original
anti-aging
tinted moisturizer
with sunscreen
Broad-Spectrum
SPF 45
NET WT 1.7 OZ | 48 g
Dist. by Revision, LP
Irving, TX 75063 Made in U.S.A.
Dist. by Revision, LP
Irving, TX 75063 Made in U.S.A.
Active ingredient Purpose
Titanium Dioxide 2.5%........ Sunscreen
Zinc Oxide 15.2% ............... Sunscreen
Active ingredient Purpose
Titanium Dioxide 2.5%........ Sunscreen
Zinc Oxide 15.2% ............... 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
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
Warnings
For external use only
Do not useon damaged or broken skin
Do not useon damaged or broken skin
When using this productkeep out of eyes. Rinse with water to remove.
When using this productkeep out of eyes. Rinse with water to remove.
Stop use and ask a doctorif rash occurs
Stop use and ask a doctorif rash occurs
Keep 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.
Directions
• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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
• children under 6 months: Ask a doctor
Directions
• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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
• children under 6 months: Ask a doctor
Inactive ingredients
Water (Aqua), Caprylic/Capric Triglyceride, Thermus Thermophillus Ferment, Diisopropyl Adipate, Polyglyceryl-2 Dipolyhydroxystearate, C12-15 Alkyl Benzoate, Bacillus Lysate, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Diisostearate, Glycerin, Hydrogenated Starch Hydrolysate, Butylene Glycol, Polyhydroxystearic Acid, Glyceryl Isostearate, Silica, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Acrylates/Dimethicone Copolymer, Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Dimethicone/Vinyl Dimethicone Crosspolymer, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Leuconostoc/Radish Root Ferment Filtrate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Melanin, Phenoxyethanol, Glyceryl Behenate/Eicosadioate, Chlorphenesin, Stearoyl Glutamic Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Magnesium Sulfate, Iron Oxides (CI 77492)
Inactive ingredients
Water (Aqua), Caprylic/Capric Triglyceride, Thermus Thermophillus Ferment, Diisopropyl Adipate, Polyglyceryl-2 Dipolyhydroxystearate, C12-15 Alkyl Benzoate, Bacillus Lysate, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Diisostearate, Glycerin, Hydrogenated Starch Hydrolysate, Butylene Glycol, Polyhydroxystearic Acid, Glyceryl Isostearate, Silica, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Acrylates/Dimethicone Copolymer, Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Dimethicone/Vinyl Dimethicone Crosspolymer, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Leuconostoc/Radish Root Ferment Filtrate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Melanin, Phenoxyethanol, Glyceryl Behenate/Eicosadioate, Chlorphenesin, Stearoyl Glutamic Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Magnesium Sulfate, Iron Oxides (CI 77492)
Other information
• protect this product from excessive heat and direct sun
Other information
• protect this product from excessive heat and direct sun
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apply liberally 15 minutes before sun exposure
reapply at least every two hours
use a water resistant sunscreen if swimming or sweating
Anti-aging untinted daily moisturizer with 100% mineral sunscreen
Broad Spectrum
SPF 50
* Please review the disclaimer below.