SPL v1
SPL
SPL Set ID 3c936ed0-ab7a-ccec-e063-6294a90afd93
Route
SUPRACHOROIDAL
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (0.2 g) Octocrylene (0.5 g)
Inactive Ingredients
Phenoxyethanol Carica Papaya (papaya) Fruit Water Cetearyl Alcohol Diisopropyl Adipate Peg-100 Stearate Benzyl Alcohol Aloe Barbadensis Leaf Psidium Guajava Fruit Xanthan Gum Butyrospermum Parkii (shea) Butter Chlorphenesin Theobroma Cacao (cocoa) Seed Butter Plumeria Rubra Flower Mangifera Indica (mango) Fruit Alpha-tocopherol Acetate Passiflora Incarnata Fruit Glyceryl Stearate Glycerin Ceteareth-20 Sodium Polyacrylate (2500000 Mw) Petrolatum Cetyl Alcohol Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Avobenzone 0.2%, Octocrylene 0.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 0.2%, Octocrylene 0.5%

Uses



• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

May stain some fabrics and surfaces.

Directions



• apply liberally 15 minutes before sun exposure• reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every two hours • children under 6 months: Ask a doctor

Do Not Use

on damaged or broken skin

Other Information

• protect this product from excessive heat and direct sun

Active Ingredients



Avobenzone 0.2%, Octocrylene 0.5%

Inactive Ingredients

Water, Petrolatum, Diisopropyl Adipate, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, Sodium Polyacrylate, Chlorphenesin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, Benzyl Alcohol, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Xanthan Gum, Disodium EDTA, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract.

Questions Or Comments?

Call 1-800-NO UV RAY, Mon-Fri

Principal Display Panel

HAWAIIAN

TROPIC

SUNSCREEN LOTION

ISLAND

TANNING

ENHANCE TAN & MOISTURIZE

COCOA BUTTER

4

DERM TESTED | VEGAN

WATER RESISTANT (80 MINUTES)

SPF 4 UVB

8 FL. OZ (236 mL)

When Using This Product

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs.

Keep Out of Reach of Children.

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


Structured Label Content

Uses



• helps prevent sunburn

Purpose

Sunscreen

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

May stain some fabrics and surfaces.

Directions



• apply liberally 15 minutes before sun exposure• reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every two hours • children under 6 months: Ask a doctor

Do Not Use (Do not use)

on damaged or broken skin

Other Information

• protect this product from excessive heat and direct sun

Active Ingredients



Avobenzone 0.2%, Octocrylene 0.5%

Inactive Ingredients

Water, Petrolatum, Diisopropyl Adipate, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Ceteareth-20, Sodium Polyacrylate, Chlorphenesin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, Benzyl Alcohol, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Xanthan Gum, Disodium EDTA, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract.

Questions Or Comments? (Questions or Comments?)

Call 1-800-NO UV RAY, Mon-Fri

Principal Display Panel

HAWAIIAN

TROPIC

SUNSCREEN LOTION

ISLAND

TANNING

ENHANCE TAN & MOISTURIZE

COCOA BUTTER

4

DERM TESTED | VEGAN

WATER RESISTANT (80 MINUTES)

SPF 4 UVB

8 FL. OZ (236 mL)

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs.

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.


Advanced Ingredient Data


Raw Label Data

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