Sun Defense Minerals (tan) Pro

Sun Defense Minerals (tan) Pro
SPL v1
SPL
SPL Set ID 2ee82379-6609-fd8e-e063-6294a90acf6c
Route
TOPICAL
Published
Effective Date 2025-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (235 mg) Titanium Dioxide (128 mg)
Inactive Ingredients
Phenylpropanol Propanediol Mauritia Flexuosa Fruit Oil Butyloctyl Salicylate Iron Oxides Aluminum Hydroxide Tridecyl Salicylate Caprylyl Glycol Hydrogenated Soybean Lecithin Octyldodecanol Tocopherol Mica Helianthus Annuus (sunflower) Seed Oil Camellia Sinensis Leaf Hydrated Silica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-03-01

Description

Directions Before use, shake or tap well Apply liberally 15 minutes before sun exposure 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 time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.


Medication Information

Warnings and Precautions

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

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

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

Directions

Before use, shake or tap well

Apply liberally 15 minutes before sun exposure

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

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

Description

Directions Before use, shake or tap well Apply liberally 15 minutes before sun exposure 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 time in the sun, especially from 10 a.m. – 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.

Section 50565-1

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

Section 51727-6

Inactive ingredients

Silica, Mica, Iron Oxides, Butyloctyl Salicylate, Octyldodecanol, Tridecyl Salicylate, Mauritia Flexuosa (Buriti) Fruit Oil, Camellia Sinensis (Green Tea) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol (Vitamin E), Phenylpropanol, Corn-Derived Propanediol, Aluminum Hydroxide, Caprylyl Glycol, Hydrogenated Plant-Derived Lecithin.

Section 51945-4

Drug Facts

Active Ingredients Purpose

Titanium Dioxide 12.8%; Zinc Oxide 23.5%......Sunscreen

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

Warnings

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

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

Directions

Before use, shake or tap well

Apply liberally 15 minutes before sun exposure

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 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

Inactive ingredients

Silica, Mica, Butyloctyl Salicylate, Octyldodecanol, Tridecyl Salicylate, Iron Oxides, Mauritia Flexuosa (Buriti) Fruit Oil, Camellia Sinensis (Green Tea) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol (Vitamin E), Phenylpropanol, Corn-Derived Propanediol, Aluminum Hydroxide, Caprylyl Glycol, Hydrogenated Plant-Derived Lecithin.

Section 55105-1

Purpose: Sunscreen

Section 55106-9

Active Ingredients Purpose

Titanium Dioxide 12.8%; Zinc Oxide 23.5%......Sunscreen


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)

Directions

Before use, shake or tap well

Apply liberally 15 minutes before sun exposure

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

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

Warnings and Precautions (34071-1)

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

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

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 51727-6 (51727-6)

Inactive ingredients

Silica, Mica, Iron Oxides, Butyloctyl Salicylate, Octyldodecanol, Tridecyl Salicylate, Mauritia Flexuosa (Buriti) Fruit Oil, Camellia Sinensis (Green Tea) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol (Vitamin E), Phenylpropanol, Corn-Derived Propanediol, Aluminum Hydroxide, Caprylyl Glycol, Hydrogenated Plant-Derived Lecithin.

Section 51945-4 (51945-4)

Drug Facts

Active Ingredients Purpose

Titanium Dioxide 12.8%; Zinc Oxide 23.5%......Sunscreen

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

Warnings

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

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

Directions

Before use, shake or tap well

Apply liberally 15 minutes before sun exposure

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 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

Inactive ingredients

Silica, Mica, Butyloctyl Salicylate, Octyldodecanol, Tridecyl Salicylate, Iron Oxides, Mauritia Flexuosa (Buriti) Fruit Oil, Camellia Sinensis (Green Tea) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol (Vitamin E), Phenylpropanol, Corn-Derived Propanediol, Aluminum Hydroxide, Caprylyl Glycol, Hydrogenated Plant-Derived Lecithin.

Section 55105-1 (55105-1)

Purpose: Sunscreen

Section 55106-9 (55106-9)

Active Ingredients Purpose

Titanium Dioxide 12.8%; Zinc Oxide 23.5%......Sunscreen


Advanced Ingredient Data


Raw Label Data

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