SPL v2
SPL
SPL Set ID 08f34b31-6337-ef7c-e063-6294a90a1c4c
Route
TOPICAL
Published
Effective Date 2023-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (3 g) Avobenzone (1 g)
Inactive Ingredients
Cocoa Butter Glyceryl Oleate Guava Passiflora Incarnata Fruit Ethylhexyl Palmitate Aloe Vera Leaf Mineral Oil Isopropyl Myristate Silicon Dioxide Papaya Plumeria Rubra Flower Tocopherol Mango Coconut Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-31

Description

Avobenzone 1.0%, Octocrylene 3.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 1.0%, Octocrylene 3.0%

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 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 40 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 1.0%, Octocrylene 3.0%

Inactive Ingredients

Ethylhexyl Palmitate, Mineral Oil, Isopropyl Myristate, Silica, Fragrance, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Aloe Barbadensis Leaf Extract.

Questions Or Comments?

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

Principal Display Panel

HAWAIIAN

TROPIC(R)

SUNSCREEN OIL SPRAY

ISLAND

TANNING

ENHANCE TAN & MOISTURIZE

COCONUT OIL

6

DERM TESTED | VEGAN

WATER RESISTANT (40 MINUTES)

SPF 6 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 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 40 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 1.0%, Octocrylene 3.0%

Inactive Ingredients

Ethylhexyl Palmitate, Mineral Oil, Isopropyl Myristate, Silica, Fragrance, Cocos Nucifera (Coconut) Oil, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Aloe Barbadensis Leaf Extract.

Questions Or Comments? (Questions or Comments?)

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

Principal Display Panel

HAWAIIAN

TROPIC(R)

SUNSCREEN OIL SPRAY

ISLAND

TANNING

ENHANCE TAN & MOISTURIZE

COCONUT OIL

6

DERM TESTED | VEGAN

WATER RESISTANT (40 MINUTES)

SPF 6 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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