Spf20 Protective Mineral Face Cream

Spf20 Protective Mineral Face Cream
SPL v2
SPL
SPL Set ID fbfccb0c-e459-3282-e053-6394a90ad95d
Route
TOPICAL
Published
Effective Date 2023-03-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (115 mg)
Inactive Ingredients
Candelilla Wax Polyhydroxystearic Acid (2300 Mw) Polyglycerin-3 Hydroxyacetophenone Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Xanthan Gum Trisodium Ethylenediamine Disuccinate Medium-chain Triglycerides Propanediol Dimethicone Glycerin Shea Butter Argan Oil 1,2-hexanediol Water Alpha-tocopherol Acetate Polyglyceryl-2 Stearate Sunflower Oil Unsaponifiables Jojoba Oil Soybean Oil Corn Oil Jojoba Oil, Randomized Rice Germ Cucumber Pongamia Pinnata Seed Levomenol Glyceryl Monostearate Stearyl Alcohol Panthenol Betasizofiran

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-03-01

Description

ACTIVE INGREDIENT: Zinc Oxide, 11.5%

Purpose

PURPOSE: Sunscreen


Medication Information

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. 

Purpose

PURPOSE: Sunscreen

Description

ACTIVE INGREDIENT: Zinc Oxide, 11.5%

Section 43683-2

Updated DIRECTIONS from Section Type "Indications & Usage" to "Dosage & Administration" on 12/2024. No content changed on the label itself.

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

Warnings

For external use only.

Directions

DIRECTIONS:

- Apply liberally 15 minutes before sun exposure

- Reapply at least every 2 hours

- Use a water resistant sunscreen if swimming or sweating

- 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 10am-2pm

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

Active Ingredient

ACTIVE INGREDIENT: Zinc Oxide, 11.5%

Other Information

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

Inactive Ingredients

INACTIVE INGREDIENTS:

Water (Aqua), Caprylic/Capric Triglyceride, Propanediol, Dimethicone, Glycerin, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, 1,2-Hexanediol, Tocopheryl Acetate, Polyglyceryl-2 Stearate, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Simmondsia Chinensis (Jojoba) Seed Oil, Glycine Soja (Soybean) Oil, Vegetable Oil, Jojoba Esters, Oryza Sativa (Rice) Germ Extract, Oryza Sativa (Rice) Extract, Hydrogenated Vegetable Oil, Cucumis Sativus (Cucumber) Fruit Extract, Pongamia Pinnata Seed Extract, Euphorbia Cerifera (Candelilla) Wax, Panthenol, Bisabolol, Glyceryl Stearate, Polyhydroxystearic Acid, Stearyl Alcohol, Sclerotium Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Polyglyceryl-3 Diisostearate, Hydroxyacetophenone, Trisodium Ethylenediamine Disuccinate


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. 

Section 43683-2 (43683-2)

Updated DIRECTIONS from Section Type "Indications & Usage" to "Dosage & Administration" on 12/2024. No content changed on the label itself.

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)

PURPOSE: Sunscreen

Warnings (WARNINGS)

For external use only.

Directions (DIRECTIONS)

DIRECTIONS:

- Apply liberally 15 minutes before sun exposure

- Reapply at least every 2 hours

- Use a water resistant sunscreen if swimming or sweating

- 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 10am-2pm

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

Active Ingredient (ACTIVE INGREDIENT)

ACTIVE INGREDIENT: Zinc Oxide, 11.5%

Other Information (OTHER INFORMATION)

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

Inactive Ingredients (INACTIVE INGREDIENTS)

INACTIVE INGREDIENTS:

Water (Aqua), Caprylic/Capric Triglyceride, Propanediol, Dimethicone, Glycerin, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, 1,2-Hexanediol, Tocopheryl Acetate, Polyglyceryl-2 Stearate, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Simmondsia Chinensis (Jojoba) Seed Oil, Glycine Soja (Soybean) Oil, Vegetable Oil, Jojoba Esters, Oryza Sativa (Rice) Germ Extract, Oryza Sativa (Rice) Extract, Hydrogenated Vegetable Oil, Cucumis Sativus (Cucumber) Fruit Extract, Pongamia Pinnata Seed Extract, Euphorbia Cerifera (Candelilla) Wax, Panthenol, Bisabolol, Glyceryl Stearate, Polyhydroxystearic Acid, Stearyl Alcohol, Sclerotium Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Xanthan Gum, Polyglyceryl-3 Diisostearate, Hydroxyacetophenone, Trisodium Ethylenediamine Disuccinate


Advanced Ingredient Data


Raw Label Data

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