Tinted Moisturizer Matte Broad Spectrum

Tinted Moisturizer Matte Broad Spectrum
SPL v5
SPL
SPL Set ID 68628b3a-2525-46a5-8d0e-253f45ace22e
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 NOT FINAL Active Since 2013-06-22

Description

Intellishade® Matte anti-aging tinted moisturizer with sunscreen Broad-Spectrum SPF 45 NET WT 1.7 OZ | 48 g

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

Description

Intellishade® Matte anti-aging tinted moisturizer with sunscreen Broad-Spectrum SPF 45 NET WT 1.7 OZ | 48 g

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 doctor if rash occurs

Section 50567-7

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

Section 50570-1

Do not use on damaged or broken skin

Section 51945-4

1.7oz IM

8oz IM

3g IM

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, 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.

Active Ingredient ........ Purpose

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

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

Titanium Dioxide 4% ...... Sunscreen

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


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

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 doctor if rash occurs

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51945-4 (51945-4)

1.7oz IM

8oz IM

3g IM

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, 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.

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

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

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

Titanium Dioxide 4% ...... Sunscreen

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


Advanced Ingredient Data


Raw Label Data

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