Intellishade Truphysical Spf 45

Intellishade Truphysical Spf 45
SPL v11
SPL
SPL Set ID e20f5dc9-e863-b090-e053-2a95a90a5044
Route
TOPICAL
Published
Effective Date 2018-03-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.4 g) Zinc Oxide (14.4 g)
Inactive Ingredients
Magnesium Chloride Benzoic Acid Sorbic Acid Triethoxycaprylylsilane Magnesium Sulfate Heptahydrate Water Medium-chain Triglycerides Thermus Thermophilus Polyglyceryl-2 Dipolyhydroxystearate Alkyl (c12-15) Benzoate Dicaprylyl Carbonate Cyclomethicone 5 Dimethicone Polyglyceryl-3 Diisostearate Sorbitol Glycerin Butylene Glycol Aloe Vera Leaf White Wax Squalane .alpha.-tocopherol Acetate, Dl- Tetrahexyldecyl Ascorbate .alpha.-tocopherol Palmitoyl Tripeptide-5 Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Lecithin, Soybean Palmitoyllysylvalyldiaminobutyroylthreonine Leuconostoc/radish Root Ferment Filtrate Yeast, Unspecified Boron Nitride Epigallocatechin Gallate Ubiquinone Q2 Melanin Synthetic (tyrosine, Peroxide) Phenoxyethanol Silicon Dioxide Chlorphenesin Polyhydroxystearic Acid (2300 Mw) Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-03-05

Description

ITP_carton_retail_ITC6_V2_OL.jpg ITP_retail_tube_ITR6_V2_OL.jpg


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and 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

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

ITP_carton_retail_ITC6_V2_OL.jpg ITP_retail_tube_ITR6_V2_OL.jpg

Section 42229-5

Intellishade®

TruPhysical



anti-aging tinted

daily moisturizer

with 100% mineral sunscreen



Broad-Spectrum

SPF 45

Moisturize & Protect

Net Wt

1.7 Oz 48g

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 ifrash 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 51727-6

Inactive ingredients Water (Aqua), Caprylic/Capric Triglyceride, Thermus Thermophillus Ferment, Polyglyceryl-2 Dipolyhydroxystearate, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Diisostearate, Glycerin, Hydrogenated Starch Hydrolysate, Butylene Glycol, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Beeswax (Cera Alba), Acrylates/Dimethicone Copolymer, Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Dimethicone/Vinyl Dimethicone Crosspolymer, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Leuconostoc/Radish Root Ferment Filtrate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Melanin, Phenoxyethanol, Silica, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Triethoxycaprylylsilane, Magnesium Sulfate, Iron Oxides (CI 77491, CI 77492, CI 77499)

Section 51945-4

Section 55105-1

Anti-aging tinted daily moisturizer with 100% mineral sunscreen

Broad Spectrum

SPF 45

Section 55106-9

Active ingredient Purpose

Zinc Oxide 14.4% ......... Sunscreen

Titanium Dioxide 4.4% . Sunscreen

Section 59845-8

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

Section 60561-8

Other information

• protect this product from excessive heat and direct sun

8oz Revision Intellishade® Tru Physical

ITP_pro_tube_ITP6_V1_OL.jpg

1.7oz Revision Intellishade® Truephysical

ITP_carton_retail_ITC6_V2_OL.jpg

ITP_retail_tube_ITR6_V2_OL.jpg


Structured Label Content

Indications and Usage (34067-9)

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

Intellishade®

TruPhysical



anti-aging tinted

daily moisturizer

with 100% mineral sunscreen



Broad-Spectrum

SPF 45

Moisturize & Protect

Net Wt

1.7 Oz 48g

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 ifrash 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 51727-6 (51727-6)

Inactive ingredients Water (Aqua), Caprylic/Capric Triglyceride, Thermus Thermophillus Ferment, Polyglyceryl-2 Dipolyhydroxystearate, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Cyclopentasiloxane, Dimethicone, Polyglyceryl-3 Diisostearate, Glycerin, Hydrogenated Starch Hydrolysate, Butylene Glycol, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Beeswax (Cera Alba), Acrylates/Dimethicone Copolymer, Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Dimethicone/Vinyl Dimethicone Crosspolymer, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Leuconostoc/Radish Root Ferment Filtrate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Melanin, Phenoxyethanol, Silica, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride, Benzoic Acid, Sorbic Acid, Triethoxycaprylylsilane, Magnesium Sulfate, Iron Oxides (CI 77491, CI 77492, CI 77499)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-aging tinted daily moisturizer with 100% mineral sunscreen

Broad Spectrum

SPF 45

Section 55106-9 (55106-9)

Active ingredient Purpose

Zinc Oxide 14.4% ......... Sunscreen

Titanium Dioxide 4.4% . Sunscreen

Section 59845-8 (59845-8)

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

Section 60561-8 (60561-8)

Other information

• protect this product from excessive heat and direct sun

8oz Revision Intellishade® Tru Physical

ITP_pro_tube_ITP6_V1_OL.jpg

1.7oz Revision Intellishade® Truephysical (1.7oz Revision Intellishade® TruePhysical)

ITP_carton_retail_ITC6_V2_OL.jpg

ITP_retail_tube_ITR6_V2_OL.jpg


Advanced Ingredient Data


Raw Label Data

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