SPL v1
SPL
SPL Set ID 3e0eb291-6bda-2f26-e063-6294a90ac466
Route
TOPICAL
Published
Effective Date 2025-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Petrolatum (40.2 g) Octisalate (5 g) Homosalate (10 g)
Inactive Ingredients
Hydrogenated Coconut Oil .alpha.-tocopherol Acetate Butyloctyl Salicylate Camellia Sinensis Leaf Beeswax Polyglyceryl-3 Beeswax Euphorbia Cerifera (candelilla) Wax Methyl Salicylate Microcrystalline Wax Cetyl Alcohol Synthetic Beeswax Ceresin Theobroma Cacao (cocoa) Seed Butter Butyrospermum Parkii (shea) Butter Ethylhexyl Methoxycrylene Hydrogenated Soybean Oil Helianthus Annuus (sunflower) Seed Oil Persea Gratissima (avocado) Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-01

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Petrolatum 40.2%

Purpose

Sunscreen Sunscreen Sunscreen Skin protectant


Medication Information

Purpose

Sunscreen Sunscreen Sunscreen Skin protectant

Description

Avobenzone 3% Homosalate 10% Octisalate 5% Petrolatum 40.2%

Use

• Helps protect against sunburn and chapped lips

Section 50565-1

Keep out of reach of children.

Section 51945-4

Section 55106-9

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Petrolatum 40.2%

Purposes

Sunscreen

Sunscreen

Sunscreen

Skin protectant

Warnings

Stop use if skin rash occurs.

Directions

• Apply liberally before sun exposure and reapply every 2 hours.

Questions?

1-469-341-2700; 1-877-766-3388 www.getJackBlack.com

Inactive Ingredients

Beeswax, Ozokerite, Polyglyceryl-3 Beeswax, Butyloctyl Salicylate, Polypinene, Ethylhexyl Methoxycrylene, Hydrogenated Soybean Oil, Hydrogenated Coconut Oil, Fragrance, Theobroma Cacao (Cocoa) Seed Butter, Synthetic Beeswax, Cetyl Alcohol, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Lecithin, Helianthus Annuus (Sunflower) Seed Oil, Microcrystalline Wax, Methyl Salicylate, Camellia Sinensis Leaf Extract.


Structured Label Content

Use

• Helps protect against sunburn and chapped lips

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Petrolatum 40.2%

Purposes

Sunscreen

Sunscreen

Sunscreen

Skin protectant

Warnings

Stop use if skin rash occurs.

Directions

• Apply liberally before sun exposure and reapply every 2 hours.

Questions?

1-469-341-2700; 1-877-766-3388 www.getJackBlack.com

Inactive Ingredients (Inactive ingredients)

Beeswax, Ozokerite, Polyglyceryl-3 Beeswax, Butyloctyl Salicylate, Polypinene, Ethylhexyl Methoxycrylene, Hydrogenated Soybean Oil, Hydrogenated Coconut Oil, Fragrance, Theobroma Cacao (Cocoa) Seed Butter, Synthetic Beeswax, Cetyl Alcohol, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Persea Gratissima (Avocado) Oil, Tocopheryl Acetate, Lecithin, Helianthus Annuus (Sunflower) Seed Oil, Microcrystalline Wax, Methyl Salicylate, Camellia Sinensis Leaf Extract.


Advanced Ingredient Data


Raw Label Data

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