Intellishade Original Spf 45

Intellishade Original Spf 45
SPL v13
SPL
SPL Set ID e213a681-eb22-69c0-e053-2995a90a899e
Route
TOPICAL
Published
Effective Date 2019-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Octisalate (5 g) Titanium Dioxide (3.5 g) Zinc Oxide (3 g)
Inactive Ingredients
Triethoxycaprylylsilane Hydrogenated Starch Hydrolysate Green Tea Leaf Tetradecyl Aminobutyroylvalylaminobutyric Urea Trifluoroacetate Cyclopentasiloxane Hydrolyzed Jojoba Esters Aloe Vera Leaf Betula Pubescens Bark White Wax Dimethicone Squalane .alpha.-tocopherol Acetate Tetrahexyldecyl Ascorbate .alpha.-tocopherol Palmitoyl Tripeptide-5 Hydrogenated Castor Oil Lecithin, Soybean Palmitoyllysylvalyldiaminobutyroylthreonine Glyceryl Caprylate Yeast Boron Nitride Epigallocatechin Gallate Ubidecarenone Simmondsia Chinensis Seed Sodium Chloride Phenoxyethanol Glyceryl Isostearate Chlorphenesin Polyhydroxystearic Acid (2300 Mw) Xanthan Gum Magnesium Chloride Benzoic Acid Sorbic Acid Polyglyceryl-4 Isostearate Water Ethylhexyl Stearate Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Hexyl Laurate Glycerin Butylene Glycol Cetyl Dimethicone 25 Caprylic/capric Acid

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-07-09

Description

ITO_carton_retail_IOC9_V4_OL.jpg ITO_tube_retail_IOR5_V3_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

ITO_carton_retail_IOC9_V4_OL.jpg ITO_tube_retail_IOR5_V3_OL.jpg

Section 42229-5

Intellishade®

Original

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 51727-6

Inactive ingredients

Water (Aqua), Cyclopentasiloxane, Jojoba Esters, Hydrogenated Starch Hydrolysate, Caprylic/Capric Triglyceride, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Butylene Glycol, Cetyl Dimethicone, Ethylhexyl Palmitate, Ethylhexyl Stearate, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Beeswax (Cera Alba), Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Hydrogenated Castor Oil, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Glyceryl Caprylate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Sodium Chloride, Phenoxyethanol, Glyceryl Isostearate, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride, Triethoxycaprylylsilane, Benzoic Acid, Sorbic Acid, Iron Oxides (CI 77491, CI 77492, CI 77499)

Section 51945-4

Section 55105-1

Anti-aging untinted daily moisturizer with 100% mineral sunscreen

Broad Spectrum

SPF 50

Section 55106-9

Active ingredient           Purpose

Octinoxate 7.5% ............ Sunscreen

Octisalate 5% ................ Sunscreen

Titanium Dioxide 3.5%... Sunscreen

Zinc Oxide 3% ............... 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® Original

ITO_pro_tube_IOP6_V2_OL.jpg

1.7oz Revision Intellishade® Original

ITO_carton_retail_IOC9_V4_OL.jpg

ITO_tube_retail_IOR5_V3_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®

Original

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 51727-6 (51727-6)

Inactive ingredients

Water (Aqua), Cyclopentasiloxane, Jojoba Esters, Hydrogenated Starch Hydrolysate, Caprylic/Capric Triglyceride, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Polyglyceryl-4 Isostearate, Butylene Glycol, Cetyl Dimethicone, Ethylhexyl Palmitate, Ethylhexyl Stearate, Aloe Barbadensis Leaf Juice, Betula Alba Bark Extract, Camellia Sinensis Leaf Extract, Plankton Extract, Beeswax (Cera Alba), Squalane, Tocopheryl Acetate, Tetrahexyldecyl Ascorbate, Tocopherol, Palmitoyl Tripeptide-5, Hydrogenated Castor Oil, Lecithin, Palmitoyl Dipeptide-5 Diaminobutyroyl Hydroxythreonine, Glyceryl Caprylate, Tetradecyl Aminobutyroylvalylaminobutyric Urea Acetate, Yeast Extract (Faex), Boron Nitride, Epigallocatechin Gallate, Ubiquinone, Simmondsia Chinensis (Jojoba) Meal Extract, Sodium Chloride, Phenoxyethanol, Glyceryl Isostearate, Chlorphenesin, Polyhydroxystearic Acid, Xanthan Gum, Magnesium Chloride, Triethoxycaprylylsilane, Benzoic Acid, Sorbic Acid, Iron Oxides (CI 77491, CI 77492, CI 77499)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-aging untinted daily moisturizer with 100% mineral sunscreen

Broad Spectrum

SPF 50

Section 55106-9 (55106-9)

Active ingredient           Purpose

Octinoxate 7.5% ............ Sunscreen

Octisalate 5% ................ Sunscreen

Titanium Dioxide 3.5%... Sunscreen

Zinc Oxide 3% ............... 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® Original

ITO_pro_tube_IOP6_V2_OL.jpg

1.7oz Revision Intellishade® Original

ITO_carton_retail_IOC9_V4_OL.jpg

ITO_tube_retail_IOR5_V3_OL.jpg


Advanced Ingredient Data


Raw Label Data

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