FDA Label for Intellishade Original Spf 45

View Indications, Usage & Precautions

Intellishade Original Spf 45 Product Label

The following document was submitted to the FDA by the labeler of this product Revision, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

1.7Oz Revision Intellishade® Original




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


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