SPL v1
SPL
SPL Set ID 2cb7773f-9a05-ad02-e063-6294a90af024
Route
TOPICAL
Published
Effective Date 2024-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (140 mg) Titanium Dioxide (37 mg)
Inactive Ingredients
Propanediol 1,2-hexanediol Silicon Dioxide Carthamus Tinctorius (safflower) Oleosomes Rosa Rubiginosa Seed Oil Polyhydroxystearic Acid (2300 Mw) Phenylpropanol Water Undecane Dicaprylyl Ether Argania Spinosa Kernel Oil Cetyl Ethylhexanoate Stearic Acid Potassium Sorbate Bisabolol Helianthus Annuus (sunflower) Seed Oil Sodium Chloride Dextrin Palmitate (corn; 20000 Mw) Hydroxyacetophenone Dunaliella Salina C13-15 Alkane Tridecane Stearyl Citrate Trioctyldodecyl Citrate Aluminum Hydroxide Thermus Thermophilus Lysate Cocos Nucifera (coconut) Oil Cucumber Aloe Barbadensis Leaf Juice Vitis Vinifera (grape) Seed Oil Pongamia Glabra Seed Oil Magnolia Officinalis Bark Cocos Nucifera (coconut) Fruit Juice Helianthus Annuus (sunflower) Seed Oil Unsaponifiables Persea Gratissima (avocado) Oil Methyl Diisopropyl Propionamide Pongamia Pinnata Seed Xanthan Gum Glycerin Cetyl Glyceryl Ether Sodium Phytate Caprylyl Glycol Caprylic/capric Triglyceride .alpha.-tocopherol Acetate Polyglyceryl-6 Polyricinoleate Haematococcus Pluvialis

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-18

Description

Titanium Dioxide 3.7% Zinc Oxide 14%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 3.7% Zinc Oxide 14%

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 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

Section 69718-5

Purpose:

Sunscreen

Warnings:

• For external use only.

Directions:

• Shake well before use.

• Apply liberally 15 minutes before sun exposure and as needed.

• Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours

• Children under 6 months of age: ask a doctor. •

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 your time in the sun, especially from 10 a.m. – 2 p.m.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information:

• Protect the product in this container from excessive heat and direct sun.

Active Ingredients:

Titanium Dioxide 3.7% Zinc Oxide 14%

Inactive Ingredients:

Water (Aqua), Cetyl Ethylhexanoate, Undecane, Caprylic/Capric Triglyceride, C13-15 Alkane, Dicaprylyl Ether, Tridecane, Argania Spinosa Kernel Oil, Propanediol, Tocopheryl Acetate, 1,2-Hexanediol, Polyglyceryl-6 Polyricinoleate, Polyhydroxystearic Acid, Silica, Stearyl Citrate, Trioctyldodecyl Citrate, Aluminum Hydroxide, Stearic Acid, Sodium Chloride, Carthamus Tinctorius (Safflower) Oleosomes, Cucumis Sativus (Cucumber) Fruit Extract, Dextrin Palmitate, Maris Limus Extract, Magnolia Officinalis Bark Extract, Thermus Thermophillus Ferment, Bisabolol, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Juice, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Persea Gratissima (Avocado) Oil, Rosa Rubiginosa Seed Oil, Vitis Vinifera (Grape) Seed Oil, Methyl Diisopropyl Propionamide, Pongamia Pinnata Seed Extract, Xanthan Gum, Cetyl Glyceryl Ether, Sodium Phytate, Glycerin, Pongamia Glabra Seed Oil, Phenylpropanol, Caprylyl Glycol, Potassium Sorbate, Hydroxyacetophenone, Dunaliella Salina Extract, Haematococcus Pluvialis Extract


Structured Label Content

Uses: (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 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)

Section 69718-5 (69718-5)

Purpose: (PURPOSE:)

Sunscreen

Warnings: (WARNINGS:)

• For external use only.

Directions: (DIRECTIONS:)

• Shake well before use.

• Apply liberally 15 minutes before sun exposure and as needed.

• Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours

• Children under 6 months of age: ask a doctor. •

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 your time in the sun, especially from 10 a.m. – 2 p.m.

• Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information: (OTHER INFORMATION:)

• Protect the product in this container from excessive heat and direct sun.

Active Ingredients: (ACTIVE INGREDIENTS:)

Titanium Dioxide 3.7% Zinc Oxide 14%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Water (Aqua), Cetyl Ethylhexanoate, Undecane, Caprylic/Capric Triglyceride, C13-15 Alkane, Dicaprylyl Ether, Tridecane, Argania Spinosa Kernel Oil, Propanediol, Tocopheryl Acetate, 1,2-Hexanediol, Polyglyceryl-6 Polyricinoleate, Polyhydroxystearic Acid, Silica, Stearyl Citrate, Trioctyldodecyl Citrate, Aluminum Hydroxide, Stearic Acid, Sodium Chloride, Carthamus Tinctorius (Safflower) Oleosomes, Cucumis Sativus (Cucumber) Fruit Extract, Dextrin Palmitate, Maris Limus Extract, Magnolia Officinalis Bark Extract, Thermus Thermophillus Ferment, Bisabolol, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Fruit Juice, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Persea Gratissima (Avocado) Oil, Rosa Rubiginosa Seed Oil, Vitis Vinifera (Grape) Seed Oil, Methyl Diisopropyl Propionamide, Pongamia Pinnata Seed Extract, Xanthan Gum, Cetyl Glyceryl Ether, Sodium Phytate, Glycerin, Pongamia Glabra Seed Oil, Phenylpropanol, Caprylyl Glycol, Potassium Sorbate, Hydroxyacetophenone, Dunaliella Salina Extract, Haematococcus Pluvialis Extract


Advanced Ingredient Data


Raw Label Data

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