Intellishade Original Spf 45 Cream
FDA Label NDC 64651-7749
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Revision, Llc for the product Intellishade Original Spf 45 (NDC 64651-7749). 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.
Label Section Quick Index
Other
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.
triple duty
sunscreen
broad spectrum
spf 45
sheer tint
net wt. 1.7oz. | 48g
Made in the USA
Distributed by Revercel LLC
Campbell, CA 95008
Dist. by Revision, LP
Irving, TX 75063 Made in U.S.A.
Otc - Active Ingredient
Active ingredient Purpose
Octinoxate 7.5% ............ Sunscreen
Octisalate 5% ................ Sunscreen
Titanium Dioxide 3.5%... Sunscreen
Zinc Oxide 3% ............... Sunscreen
Active ingredient Purpose
Octinoxate 7.5% ............ Sunscreen
Octisalate 5% ................ Sunscreen
Titanium Dioxide 3.5%... Sunscreen
Zinc Oxide 3% ............... Sunscreen
Active ingredient Purpose
Octinoxate 7.5% ............ Sunscreen
Octisalate 5% ................ Sunscreen
Titanium Dioxide 3.5%... Sunscreen
Zinc Oxide 3% ............... Sunscreen
Indications & Usage
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
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
Warnings
For external use only
Warnings
For external use only
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin
Do not use on damaged or broken skin
Do not use on damaged or broken skin
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.
When using this product keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs
Stop use and ask a doctor if rash occurs
Stop use and ask a doctor if rash occurs
Otc - Keep Out Of Reach Of Children
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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Instructions For Use
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
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 Ingredient
Inactive ingredients
Water (Aqua), Cyclopentasiloxane, Jojoba Esters, Caprylic/Capric Triglyceride, Ethylhexyl Stearate, Cetyl PEG/PPG-10/1
Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Sorbitol, Glycerin, Butylene Glycol, Cetyl Dimethicone, Aloe
Barbadensis Leaf Juice, Betula Alba (White Birch) Bark Extract, Camellia Sinensis (Green Tea) Leaf Extract, Plankton Extract,
Beeswax, Dimethicone, Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5,
Hydrogenated Castor Oil, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Glyceryl Caprylate, Tetradecyl
Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate,
Ubiquinone, Jojoba Bean Meal, Sodium Chloride, Phenoxyethanol, Glyceryl Isostearate, Chlorphenesin, Polyhydroxystearic
Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Iron Oxides.
Inactive ingredients
Water (Aqua), Cyclopentasiloxane, Jojoba Esters, Caprylic/Capric Triglyceride, Ethylhexyl Stearate, Cetyl PEG/PPG-10/1
Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Sorbitol, Glycerin, Butylene Glycol, Cetyl Dimethicone, Aloe
Barbadensis Leaf Juice, Betula Alba (White Birch) Bark Extract, Camellia Sinensis (Green Tea) Leaf Extract, Plankton Extract,
Beeswax, Dimethicone, Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5,
Hydrogenated Castor Oil, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Glyceryl Caprylate, Tetradecyl
Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate,
Ubiquinone, Jojoba Bean Meal, Sodium Chloride, Phenoxyethanol, Glyceryl Isostearate, Chlorphenesin, Polyhydroxystearic
Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Iron Oxides.
Inactive ingredients
Water (Aqua), Cyclopentasiloxane, Jojoba Esters, Caprylic/Capric Triglyceride, Ethylhexyl Stearate, Cetyl PEG/PPG-10/1
Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Sorbitol, Glycerin, Butylene Glycol, Cetyl Dimethicone, Aloe
Barbadensis Leaf Juice, Betula Alba (White Birch) Bark Extract, Camellia Sinensis (Green Tea) Leaf Extract, Plankton Extract,
Beeswax, Dimethicone, Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5,
Hydrogenated Castor Oil, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Glyceryl Caprylate, Tetradecyl
Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate,
Ubiquinone, Jojoba Bean Meal, Sodium Chloride, Phenoxyethanol, Glyceryl Isostearate, Chlorphenesin, Polyhydroxystearic
Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Iron Oxides.
Other Safety Information
Other information
• protect this product from excessive heat and direct sun
Other information
• protect this product from excessive heat and direct sun
Other information
• protect this product from excessive heat and direct sun
Package Label.Principal Display Panel
1.7oz IO
1.7oz TD
8oz IO
3g IO
* Please review the disclaimer below.
