Intellishade Matte Spf 45

Intellishade Matte Spf 45
SPL v14
SPL
SPL Set ID e213ae87-4db2-3070-e053-2995a90a083b
Route
TOPICAL
Published
Effective Date 2019-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (5.5 g) Octisalate (3.5 g) Titanium Dioxide (4 g) Zinc Oxide (3 g)
Inactive Ingredients
Water Cyclomethicone 5 Medium-chain Triglycerides Cetearyl Olivate Sorbitol Glycerin Sorbitan Olivate Butylene Glycol Dimethicone Aloe Vera Leaf Isodecyl Neopentanoate Diisopropyl Sebacate Sorbitan Monostearate Tetrahexyldecyl Ascorbate Glyceryl Monostearate Tocopherol Allantoin Lauryl Lactate Squalane Yeast Betula Pubescens Bark Silicon Dioxide Lecithin, Soybean Cetyl Alcohol Peg-100 Stearate Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Polysorbate 60 Palmitoyl Tripeptide-5 Epigallocatechin Gallate Ubidecarenone Simmondsia Chinensis Seed Glyceryl Isostearate .alpha.-tocopherol Acetate Polyhydroxystearic Acid (2300 Mw) Boron Nitride Phenoxyethanol Chlorphenesin Hydroxyethyl Cellulose (2000 Cps At 1%) Xanthan Gum Magnesium Chloride Triethoxycaprylylsilane Sorbic Acid Benzoic Acid Ferric Oxide Red

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-06-22

Description

ITM_retail_carton_IMC5 ITM_retail_tube_IMR5

Purpose

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


Medication Information

Purpose

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

Dosage and Administration

apply liberally 15 minutes before sun exposure

reapply at least every two hours

use a water resistant sunscreen if swimming or sweating

Description

ITM_retail_carton_IMC5 ITM_retail_tube_IMR5

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

Section 42229-5

Intellishade®

Matte

anti-aging

tinted moisturizer

with sunscreen

Broad-Spectrum

SPF 45

NET WT 1.7 OZ | 48 g

Section 50565-1

Keep 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 doctorif rash occurs

Section 50567-7

When using this productkeep out of eyes. Rinse with water to remove.

Section 50570-1

Do not useon damaged or broken skin

Section 51945-4

Section 55105-1

Anti-aging tinted daily moisturizer with sunscreen

Broad Spectrum

SPF 45

Warnings

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

Other Information

• protect this product from excessive heat and direct sun

Inactive Ingredients

Water (Aqua), Cyclopentasiloxane, Hydrogenated Starch Hydrolysate, Caprylic/Capric Triglyceride, Cetearyl Olivate, Glycerin, Butylene Glycol, Sorbitan Olivate, 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 Bark Extract, Camellia Sinensis Leaf Extract, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Silica, Lecithin, Cetyl Alcohol, PEG-100 Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Palmitoyl Tripeptide-5, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Glyceryl Isostearate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Tocopheryl Acetate, Polyhydroxystearic Acid, Boron Nitride, Phenoxyethanol, Chlorphenesin, Hydroxyethylcellulose, Xanthan Gum, Magnesium Chloride, Triethoxycaprylylsilane, Sorbic Acid, Benzoic Acid, Iron Oxides (CI 77491, CI 77492, CI 77499)

8oz Revision Intellishade® Matte

ITM_pro_tube_IMP6

Active Ingredient ........ Purpose

Octinoxate 5.5% ........... Sunscreen

Octisalate 3.5% ............. Sunscreen

Titanium Dioxide 4% ...... Sunscreen

Zinc Oxide 3% .............. Sunscreen

1.7oz Revision Intellishade® Matte

ITM_retail_carton_IMC5

ITM_retail_tube_IMR5


Structured Label Content

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

Dosage and Administration (34068-7)

apply liberally 15 minutes before sun exposure

reapply at least every two hours

use a water resistant sunscreen if swimming or sweating

Section 42229-5 (42229-5)

Intellishade®

Matte

anti-aging

tinted moisturizer

with sunscreen

Broad-Spectrum

SPF 45

NET WT 1.7 OZ | 48 g

Section 50565-1 (50565-1)

Keep 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 doctorif rash occurs

Section 50567-7 (50567-7)

When using this productkeep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not useon damaged or broken skin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-aging tinted daily moisturizer with sunscreen

Broad Spectrum

SPF 45

Warnings

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

Other Information (Other information)

• protect this product from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Cyclopentasiloxane, Hydrogenated Starch Hydrolysate, Caprylic/Capric Triglyceride, Cetearyl Olivate, Glycerin, Butylene Glycol, Sorbitan Olivate, 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 Bark Extract, Camellia Sinensis Leaf Extract, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Silica, Lecithin, Cetyl Alcohol, PEG-100 Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polysorbate 60, Palmitoyl Tripeptide-5, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Glyceryl Isostearate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Tocopheryl Acetate, Polyhydroxystearic Acid, Boron Nitride, Phenoxyethanol, Chlorphenesin, Hydroxyethylcellulose, Xanthan Gum, Magnesium Chloride, Triethoxycaprylylsilane, Sorbic Acid, Benzoic Acid, Iron Oxides (CI 77491, CI 77492, CI 77499)

8oz Revision Intellishade® Matte

ITM_pro_tube_IMP6

Active Ingredient ........ Purpose (Active ingredient ........ Purpose)

Octinoxate 5.5% ........... Sunscreen

Octisalate 3.5% ............. Sunscreen

Titanium Dioxide 4% ...... Sunscreen

Zinc Oxide 3% .............. Sunscreen

1.7oz Revision Intellishade® Matte

ITM_retail_carton_IMC5

ITM_retail_tube_IMR5


Advanced Ingredient Data


Raw Label Data

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