SPL v2
SPL
SPL Set ID 4685ff24-0bb0-3502-e063-6394a90abfee
Route
TOPICAL
Published
Effective Date 2026-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (2.85 g) Octisalate (1.44 g) Avobenzone (0.84 g) Homosalate (2.19 g)
Inactive Ingredients
Hyaluronic Acid Oenothera Biennis Flower Cetearyl Alcohol Butyloctyl Salicylate Pentylene Glycol Silica Isopropyl Titanium Triisostearate Hedera Helix Leaf Rosa Damascena Flower Oil Dimethicone Dimethicone/bis-isobutyl Ppg-20 Crosspolymer Aluminum Hydroxide Ci 77491 Sodium Hyaluronate Pueraria Montana Var. Lobata Root Iris Germanica Var. Florentina Root Lauryl Peg-8 Dimethicone (300 Cps) Ci 77499 Peg-10 Dimethicone (600 Cst) Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Benzyl Glycol Pyrus Communis (pear) Fruit Sodium Acetylated Hyaluronate Potassium Cetyl Phosphate Tocopherol Boron Nitride 1,2-hexanediol Hydroxyapatite Magnesium Potassium Aluminosilicate Fluoride Ethylhexylglycerin Isododecane Butylene Glycol Ci 77492 Ganoderma Lucidum Stem Muskmelon Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Salix Alba Bark Water Myristic Acid Pinus Palustris Leaf Titanium Dioxide Disteardimonium Hectorite Ulmus Davidiana Root Magnesium Sulfate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-19

Description

■ 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 ■ When using this product, keep out of eyes. Rinse with water to remove

Indications and Usage

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


Medication Information

Indications and Usage

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

■ 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 ■ When using this product, keep out of eyes. Rinse with water to remove

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

■ 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

■ When using this product, keep out of eyes. Rinse with water to remove

Section 55106-9

Active Ingredient

Avobenzone 2.80%

Homosalate 7.30%

Octisalate 4.80%

Octocrylene 9.50%

Warning

For external use only. When using this product, avoid contact with eyes. Stop use and ask a doctor if irritation occurs. Keep out of reach of children.

Directions

■ Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

■ 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

■ Ask a doctor to use for children under 6 months

Otc Do Not Use

Do not use ■ on damaged skin, ■ on broken skin

Other Information

Other Information ■ Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Inactive ingredients

Isododecane, Water (Aqua), Dimethicone, Butylene Glycol, PEG-10 Dimethicone, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Pentylene Glycol, Disteardimonium Hectorite, Magnesium Sulfate, Lauryl PEG-8 Dimethicone, Synthetic Fluorphlogopite, Benzyl Glycol, Pyrus Communis (Pear) Fruit Extract, Potassium Cetyl Phosphate, Rosa Damascena Flower Water, Iris Florentina Root Extract, Silica, Ganoderma Lucidum (Mushroom) Stem Extract, Cucumis Melo (Melon) Fruit Extract, Ethylhexylglycerin, Aluminum Hydroxide, Isopropyl Titanium Triisostearate, Hedera Helix (Ivy) Leaf/Stem Extract, Boron Nitride, 1,2-Hexanediol, Hydroxyapatite, Quartz, Hydroxypropyltrimonium Hyaluronate, Myristic Acid, Cetearyl Alcohol, Sodium Hyaluronate, Oenothera Biennis (Evening Primrose) Flower, Pueraria Lobata Root Extract, Pinus Palustris Leaf Extract, Ulmus Davidiana Root Extract, Salix Alba (Willow) Bark Extract, Tocopherol, Hydrolyzed Hyaluronic Acid, Ascorbyl Propyl Hyaluronate, Sodium Acetylated Hyaluronate, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Questions Or Comments?

Questions or comments? 424-538-1951

Keep Out of Reach of Children.

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

Package Label Principal Display

Package label Principal Display


Structured Label Content

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

■ 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

■ When using this product, keep out of eyes. Rinse with water to remove

Section 55106-9 (55106-9)

Active Ingredient

Avobenzone 2.80%

Homosalate 7.30%

Octisalate 4.80%

Octocrylene 9.50%

Purpose

Purpose-Sunscreen

Warning

For external use only. When using this product, avoid contact with eyes. Stop use and ask a doctor if irritation occurs. Keep out of reach of children.

Directions

■ Apply liberally 15 minutes before sun exposure. Reapply at least every two hours

■ 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

■ Ask a doctor to use for children under 6 months

Otc Do Not Use (OTC-Do not use)

Do not use ■ on damaged skin, ■ on broken skin

Other Information

Other Information ■ Protect the product in this container from excessive heat and direct sun

Inactive Ingredients (Inactive ingredients)

Inactive ingredients

Isododecane, Water (Aqua), Dimethicone, Butylene Glycol, PEG-10 Dimethicone, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Butyloctyl Salicylate, Cetyl PEG/PPG-10/1 Dimethicone, Pentylene Glycol, Disteardimonium Hectorite, Magnesium Sulfate, Lauryl PEG-8 Dimethicone, Synthetic Fluorphlogopite, Benzyl Glycol, Pyrus Communis (Pear) Fruit Extract, Potassium Cetyl Phosphate, Rosa Damascena Flower Water, Iris Florentina Root Extract, Silica, Ganoderma Lucidum (Mushroom) Stem Extract, Cucumis Melo (Melon) Fruit Extract, Ethylhexylglycerin, Aluminum Hydroxide, Isopropyl Titanium Triisostearate, Hedera Helix (Ivy) Leaf/Stem Extract, Boron Nitride, 1,2-Hexanediol, Hydroxyapatite, Quartz, Hydroxypropyltrimonium Hyaluronate, Myristic Acid, Cetearyl Alcohol, Sodium Hyaluronate, Oenothera Biennis (Evening Primrose) Flower, Pueraria Lobata Root Extract, Pinus Palustris Leaf Extract, Ulmus Davidiana Root Extract, Salix Alba (Willow) Bark Extract, Tocopherol, Hydrolyzed Hyaluronic Acid, Ascorbyl Propyl Hyaluronate, Sodium Acetylated Hyaluronate, Titanium Dioxide (CI 77891), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Indications and Usage (Indications and usage)

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

Questions Or Comments? (Questions or comments?)

Questions or comments? 424-538-1951

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

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

Package Label Principal Display (Package label Principal Display)

Package label Principal Display


Advanced Ingredient Data


Raw Label Data

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