Bb0940

Bb0940
SPL v3
SPL
SPL Set ID 26d1506f-b2ce-403a-b8bc-9a63e5e7aa39
Route
TOPICAL
Published
Effective Date 2012-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (1.28 g) Titanium Dioxide (0.96 g)
Inactive Ingredients
Water Dimethicone Isohexadecane Mica Glycerin Ceramide 3 Trifolium Pratense Flower Ascorbyl Palmitate Alanine Aspartic Acid Glutamic Acid Mannitol Sorbitol Trehalose Urea Fructose Sucrose Cholesterol Sodium Lauroyl Lactylate Butylene Glycol Hexylene Glycol Xanthan Gum Sodium Chloride Zinc Stearate Benzoic Acid Butylparaben Ethylparaben Isobutylparaben Methylparaben Phenoxyethanol Potassium Sorbate Propylparaben Chlorphenesin

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-08-05

Description

- For normal to dry skin. - Medium to full coverage. Luminous finish. Makeup goes ultra to smooth, lift, and firm the look of skin. This moisturizing cream foundation with CPT technology, Ceramides, and Advanced Moisture Complex diminished the appearance of fine lines, perfects skin tone, and creates a luminous finish that lasts all day. Provides Broad Spectrum Sunscreen SPF 15 protection.

Indications and Usage

To Use: Smooth onto face. For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. 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 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-sleeve shirts, pants, hats, and sunglasses.

Purpose

Provides SPF 15 sun protection.


Medication Information

Indications and Usage

To Use: Smooth onto face.

For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.

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 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-sleeve shirts, pants, hats, and sunglasses.

Purpose

Provides SPF 15 sun protection.

Description

- For normal to dry skin.

- Medium to full coverage. Luminous finish.

Makeup goes ultra to smooth, lift, and firm the look of skin. This moisturizing cream foundation with CPT technology, Ceramides, and Advanced Moisture Complex diminished the appearance of fine lines, perfects skin tone, and creates a luminous finish that lasts all day. Provides Broad Spectrum Sunscreen SPF 15 protection.

Warnings

Warnings:

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Otc Purpose

Provides SPF 15 sun protection.

Otc When Using

Keep out of eyes.

Inactive Ingredient

Other Ingredients: Water/Aqua/Eau, Cyclopentasiloxane, Dimethicone, Isohexadecane, Mica, Glycerin, Sorbitan, Isostearate, Dimethicone Crosspolymer, Alumina, Caprylyl Dimethicone Ethoxy Glucoside, Aluminum/Magnesium Hydroxide Stearate, Ceramide 1, Ceramide 3, Ceramide 6 II, Alpinia Speciosa Leaf Extract, Hibiscus Abelmoschus Seed Extract, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Ascorbyl Palmitate, Retinyl palmitate, Tocopherol, Alanine, Aspartic Acide, Glumatic Acid, Silica Silyate, Acetyl Octatpeptide-3, Mannitol, Sodium PCA, Sorbitol, Trehalose, Urea, Lecithin, PCA Dimethicone, Phytosphingosine, Polyperfluoroethoxymethoxy Difluororethyl PEG Phostphate, Fructose, Glucose, Sucrose, Cholesterol, Sodium Lauroyl Lactylate, Polyquaternium-51, Dextrin, Butylene Glycol, Hexylene Glycol, Carbomer, Xanthan Gum, BHT, Sodium Choloride, Zinc Stearate, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Pottasium Sorbate, Propylparaben, Chlorphenesin, Iron Oxides (CI 77481, CI 77482), Titanium Dioxide (CI 77891).

Dosage & Administration

Smooth on to face.

Otc Active Ingredient

Active Ingredients: Octinoxate 4.0%, Titanium Dioxide 3.0%

Otc Keep Out of Reach of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel


Structured Label Content

Warnings (WARNINGS)

Warnings:

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Description (DESCRIPTION)

- For normal to dry skin.

- Medium to full coverage. Luminous finish.

Makeup goes ultra to smooth, lift, and firm the look of skin. This moisturizing cream foundation with CPT technology, Ceramides, and Advanced Moisture Complex diminished the appearance of fine lines, perfects skin tone, and creates a luminous finish that lasts all day. Provides Broad Spectrum Sunscreen SPF 15 protection.

Otc Purpose (OTC - PURPOSE)

Provides SPF 15 sun protection.

Otc When Using (OTC - WHEN USING)

Keep out of eyes.

Inactive Ingredient (INACTIVE INGREDIENT)

Other Ingredients: Water/Aqua/Eau, Cyclopentasiloxane, Dimethicone, Isohexadecane, Mica, Glycerin, Sorbitan, Isostearate, Dimethicone Crosspolymer, Alumina, Caprylyl Dimethicone Ethoxy Glucoside, Aluminum/Magnesium Hydroxide Stearate, Ceramide 1, Ceramide 3, Ceramide 6 II, Alpinia Speciosa Leaf Extract, Hibiscus Abelmoschus Seed Extract, Trifolium Pratense (Clover) Flower Extract, Sodium Hyaluronate, Ascorbyl Palmitate, Retinyl palmitate, Tocopherol, Alanine, Aspartic Acide, Glumatic Acid, Silica Silyate, Acetyl Octatpeptide-3, Mannitol, Sodium PCA, Sorbitol, Trehalose, Urea, Lecithin, PCA Dimethicone, Phytosphingosine, Polyperfluoroethoxymethoxy Difluororethyl PEG Phostphate, Fructose, Glucose, Sucrose, Cholesterol, Sodium Lauroyl Lactylate, Polyquaternium-51, Dextrin, Butylene Glycol, Hexylene Glycol, Carbomer, Xanthan Gum, BHT, Sodium Choloride, Zinc Stearate, Benzoic Acid, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Pottasium Sorbate, Propylparaben, Chlorphenesin, Iron Oxides (CI 77481, CI 77482), Titanium Dioxide (CI 77891).

Indications and Usage (INDICATIONS AND USAGE)

To Use: Smooth onto face.

For Sunscreen Use: Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.

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 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-sleeve shirts, pants, hats, and sunglasses.

Dosage & Administration (DOSAGE & ADMINISTRATION)

Smooth on to face.

Otc Active Ingredient (OTC - ACTIVE INGREDIENT)

Active Ingredients: Octinoxate 4.0%, Titanium Dioxide 3.0%

Otc Keep Out of Reach of Children (OTC - KEEP OUT OF REACH OF CHILDREN)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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