Intellishade Matte Spf 45 Cream
FDA Label NDC 64651-7603

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 Matte Spf 45 (NDC 64651-7603). 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 active ingredient ........ purpose, uses, warnings, directions, inactive ingredients, other information, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient ........ Purpose

Octinoxate 5.5% ........... Sunscreen
Octisalate 3.5% ............. Sunscreen
Titanium Dioxide 4% ...... Sunscreen
Zinc Oxide 3% .............. Sunscreen

Octinoxate 5.5% ........... Sunscreen
Octisalate 3.5% ............. Sunscreen
Titanium Dioxide 4% ...... Sunscreen
Zinc Oxide 3% .............. 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

• 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

For external use only

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

• 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), Cyclopentasiloxane, Caprylic/Capric Triglyceride, Cetearyl Olivate, Sorbitol, Glycerin, Sorbitan
Olivate, Butylene Glycol, Dimethicone, Aloe Barbadensis Leaf Juice, Isodecyl Neopentanoate, Diisopropyl Sebacate,
Sorbitan Stearate, Tetrahexyldecyl Ascorbate, Glyceryl Stearate, Tocopherol, Allantoin, Lauryl Lactate, Squalane,
Yeast Extract (Faex), Plankton Extract, Betula Alba (White Birch) Bark Extract, Camellia Sinensis
(Green Tea) Leaf Extract, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Silica, Lecithin,
Cetyl Alcohol, PEG-100 Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyltaurate Copolymer,
Polysorbate 60, Palmitoyl Tripeptide-5, Epigallocatechin Gallate, Ubiquinone, Jojoba Bean Meal, Glyceryl Isostearate,
Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Tocopheryl Acetate, Polyhydroxystearic Acid,
Boron Nitride, Phenoxyethanol, Chlorphenesin, Hydroxyethylcellulose, Xanthan Gum, Magnesium Chloride,
Triethoxycaprylylsilane, Sorbic Acid, Benzoic Acid, Iron Oxides.

Water (Aqua), Cyclopentasiloxane, Caprylic/Capric Triglyceride, Cetearyl Olivate, Sorbitol, Glycerin, Sorbitan
Olivate, Butylene Glycol, Dimethicone, Aloe Barbadensis Leaf Juice, Isodecyl Neopentanoate, Diisopropyl Sebacate,
Sorbitan Stearate, Tetrahexyldecyl Ascorbate, Glyceryl Stearate, Tocopherol, Allantoin, Lauryl Lactate, Squalane,
Yeast Extract (Faex), Plankton Extract, Betula Alba (White Birch) Bark Extract, Camellia Sinensis
(Green Tea) Leaf Extract, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Silica, Lecithin,
Cetyl Alcohol, PEG-100 Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyltaurate Copolymer,
Polysorbate 60, Palmitoyl Tripeptide-5, Epigallocatechin Gallate, Ubiquinone, Jojoba Bean Meal, Glyceryl Isostearate,
Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate, Tocopheryl Acetate, Polyhydroxystearic Acid,
Boron Nitride, Phenoxyethanol, Chlorphenesin, Hydroxyethylcellulose, Xanthan Gum, Magnesium Chloride,
Triethoxycaprylylsilane, Sorbic Acid, Benzoic Acid, Iron Oxides.

Other Information

• protect this product from excessive heat and direct sun

• protect this product from excessive heat and direct sun

Package Label.Principal Display Panel

1.7oz IM

8oz Intellishade Matte (8ozintellishadematte18 Jun)

8oz Intellishade Matte (8ozintellishadematte18 Jun)

8oz IM

3g Intellishade Matte (3gintellishadematte17 Feb)

3g Intellishade Matte (3gintellishadematte17 Feb)

3g IM

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