SPL v1
SPL
SPL Set ID 31aad575-a5d1-42b0-e063-6294a90a6c81
Route
TOPICAL
Published
Effective Date 2025-05-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (5 g) Avobenzone (1.5 g) Homosalate (6.2 g) Oxybenzone (3.1 g) Octinoxate (7.4 g)
Inactive Ingredients
Peg-100 Stearate Triethanolamine Retinyl Palmitate Camellia Sinensis Seed Ethylhexylglycerin Aloe Barbadensis Leaf Phenoxyethanol Acrylates/c10-30 Alkyl Acrylate Crosspolymer (60000 Mpa.s) Water Vitis Vinifera (grape) Carbomer 940 Glyceryl Stearate Sodium Pca Tocopherol Calcium Disodium Edta Alkyl (c12-15) Benzoate Glycerin Stearic Acid Polysorbate 60

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-08

Description

Octinoxate 7.40% Homosalate 6.20% Octisalate 5.00% Oxybenzone 3.10% Avobenzone 1.50%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octinoxate 7.40% Homosalate 6.20% Octisalate 5.00% Oxybenzone 3.10% Avobenzone 1.50%

Uses

Helps prevent sunburn.

Warnings

For external use only. Do not use on damaged or broken skin.

Keep out of eyes. If contact occurs, rinse with water. If rash or irritation develops, discontinue use and consult your physician.

Directions

After cleansing, apply liberally and evenly 15 minutes before sun exposure. Smooth over face and neck and chest daily for optimal results.

Reapply at least every two (2) hours.

Use 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. For children under 6 months of age: Ask doctor.

Other Information

Protect the product in this container from excessive heat and direct sun. Store at room temperature

Active Ingredients

Octinoxate 7.40%

Homosalate 6.20%

Octisalate 5.00%

Oxybenzone 3.10%

Avobenzone 1.50%

Inactive Ingredients

Aqua, C12-15 Alkyl Benzoate, Glycerin, Glyceryl Stearate, Stearic Acid, PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin, Polysorbate 60, Acrylates/010-30 Alyl Acrylate Crosspolymer, Carbomer, Triethanolamine, Fragrance, Tocopherol, Retinyl Palmitate, Aloe Barbadensis Leaf Extract, Camellia Sinensis Extract, Sodium PCA, Vitis Vinifera (Grape) Fruit Cell Extract, Disodium EDTA

Stop Using This Product

Stop using this product and ask doctor if rash or redness develops and lasts

Keep Out of Reach of Children.

If accidental ingestion, call the Poison Control Center right away.

Prismastem Face Shield Cream Spf 30 2.1oz


Structured Label Content

Uses

Helps prevent sunburn.

Purpose

Sunscreen

Warnings

For external use only. Do not use on damaged or broken skin.

Keep out of eyes. If contact occurs, rinse with water. If rash or irritation develops, discontinue use and consult your physician.

Directions

After cleansing, apply liberally and evenly 15 minutes before sun exposure. Smooth over face and neck and chest daily for optimal results.

Reapply at least every two (2) hours.

Use 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. For children under 6 months of age: Ask doctor.

Other Information

Protect the product in this container from excessive heat and direct sun. Store at room temperature

Active Ingredients

Octinoxate 7.40%

Homosalate 6.20%

Octisalate 5.00%

Oxybenzone 3.10%

Avobenzone 1.50%

Inactive Ingredients

Aqua, C12-15 Alkyl Benzoate, Glycerin, Glyceryl Stearate, Stearic Acid, PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin, Polysorbate 60, Acrylates/010-30 Alyl Acrylate Crosspolymer, Carbomer, Triethanolamine, Fragrance, Tocopherol, Retinyl Palmitate, Aloe Barbadensis Leaf Extract, Camellia Sinensis Extract, Sodium PCA, Vitis Vinifera (Grape) Fruit Cell Extract, Disodium EDTA

Stop Using This Product (Stop using this product)

Stop using this product and ask doctor if rash or redness develops and lasts

Keep Out of Reach of Children. (Keep out of reach of children.)

If accidental ingestion, call the Poison Control Center right away.

Prismastem Face Shield Cream Spf 30 2.1oz (Prismastem Face Shield Cream SPF 30 2.1oz)


Advanced Ingredient Data


Raw Label Data

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