af88b74b-286a-c8d6-e053-2995a90af656

SPL v1
SPL
SPL Set ID af88b74b-286a-c8d6-e053-2995a90af656
Route
topical
Published
Effective Date 2020-09-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octinoxate (7.5 g) avobenzone (2.2 g)
Inactive Ingredients
phosphatidylcholine, soybean melissa officinalis alcohol lavender oil water hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (45000 mpa.s at 1%) hydroxypropyl distarch phosphate, high amylose corn glycerin buddleja davidii leaf peucedanum ostruthium leaf butylene glycol leuconostoc/radish root ferment filtrate sodium hydroxide octyldodecyl neopentanoate phenethyl benzoate .alpha.-tocopherol acetate corn oil haslea ostrearia chamaemelum nobile flower oil dimethicone glycereth-26 apple phenoxyethanol sorbitan isostearate artemisia umbelliformis flower rosemary oil carbomer homopolymer, unspecified type hyaluronate sodium edetate disodium anhydrous cetearyl glucoside leontopodium alpinum flowering top pelargonium graveolens flower oil vitamin a palmitate calendula officinalis flower polysorbate 60 palmaria palmata cyclomethicone 5 iodopropynyl butylcarbamate

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2020-09-17
Purpose

Sunscreen

Description

Avobenzone 2.2%, Octinoxate 7.5%

Medication Information

Warnings

For external use only

Purpose

Sunscreen

Directions

Apply liberally 15 minutes before sun exposure

Use a water-resistant sunscreen if swimming or sweating

Reapply at least every two hours

Children under 6 months: 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 sunscreen with a broad-spectrum SPF value of 15 or higher • Limit time in the sun, especially from 10 a.m.–2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

Protect product from excessive heat and direct sunlight

You may report a serious adverse reaction from using this product to Jack Black at 1-877-766-3388.

Inactive Ingredients

Aqua (Water), Cyclopentasiloxane, Octyldodecyl Neopentanoate, Phenethyl Benzoate, Dimethicone, Glycereth-26, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Hydroxypropyl Starch Phosphate, Cetearyl Glucoside, Carbomer, Pyrus Malus (Apple) Fruit Extract, Butylene Glycol, Sodium Hydroxide, Disodium EDTA, Sodium Hyaluronate, Lavandula Angustifolia (Lavender) Oil, Iodopropynyl Butylcarbamate, Pelargonium Graveolens Flower Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Lecithin, Melissa Officinalis Extract, Haslea Ostrearia Extract, Palmaria Palmata Extract, Calendula Officinalis Flower Extract*, Glycerin, Leontopodium Alpinum (Edelweiss) Extract*, Retinyl Palmitate, Tocopheryl Acetate, Anthemis

Nobilis Flower Oil, Peucedanum Ostruthium Leaf Extract*, Buddleja Davidii Leaf Extract*, Artemisia Umbelliformis Extract*

*Certified Organic

Description

Avobenzone 2.2%, Octinoxate 7.5%

Questions?

1-877-766-3388

www.getjackblack.com

Use

Moisturizes and helps prevent sunburn.

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Section 50566-9

Stop use and ask 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

Active Ingredient

Avobenzone 2.2%, Octinoxate 7.5%

Structured Label Content

Warnings

For external use only

Purpose

Sunscreen

Directions

Apply liberally 15 minutes before sun exposure

Use a water-resistant sunscreen if swimming or sweating

Reapply at least every two hours

Children under 6 months: 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 sunscreen with a broad-spectrum SPF value of 15 or higher • Limit time in the sun, especially from 10 a.m.–2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

Protect product from excessive heat and direct sunlight

You may report a serious adverse reaction from using this product to Jack Black at 1-877-766-3388.

Inactive Ingredients

Aqua (Water), Cyclopentasiloxane, Octyldodecyl Neopentanoate, Phenethyl Benzoate, Dimethicone, Glycereth-26, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Hydroxypropyl Starch Phosphate, Cetearyl Glucoside, Carbomer, Pyrus Malus (Apple) Fruit Extract, Butylene Glycol, Sodium Hydroxide, Disodium EDTA, Sodium Hyaluronate, Lavandula Angustifolia (Lavender) Oil, Iodopropynyl Butylcarbamate, Pelargonium Graveolens Flower Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Lecithin, Melissa Officinalis Extract, Haslea Ostrearia Extract, Palmaria Palmata Extract, Calendula Officinalis Flower Extract*, Glycerin, Leontopodium Alpinum (Edelweiss) Extract*, Retinyl Palmitate, Tocopheryl Acetate, Anthemis

Nobilis Flower Oil, Peucedanum Ostruthium Leaf Extract*, Buddleja Davidii Leaf Extract*, Artemisia Umbelliformis Extract*

*Certified Organic

Questions?

1-877-766-3388

www.getjackblack.com

Use

Moisturizes and helps prevent sunburn.

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask 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)

Active Ingredient

Avobenzone 2.2%, Octinoxate 7.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:38.884536 · Updated: 2026-03-14T22:59:43.649746