SPL v2
SPL
SPL Set ID 0b625d48-9632-0464-e063-6394a90a9adc
Route
TOPICAL
Published
Effective Date 2023-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (2.5 g) Avobenzone (2 g) Octocrylene (3 g)
Inactive Ingredients
Aloe Vera Leaf D&c Red No. 17 Cocoa Butter Corn Oil Polybutene (1400 Mw) Coconut Oil Tartaric Acid Carrot Histidine Ethylhexyl Palmitate D&c Yellow No. 11 Papaya Mineral Oil Plumeria Rubra Flower Phenyl Trimethicone Alpha-tocopherol Acetate Passiflora Incarnata Fruit Soybean Oil Glyceryl Oleate Beta Carotene Guava Mango Silicon Dioxide Arginine Isopropyl Myristate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-30 Until 2027-09-11

Description

Avobenzone 2.0%, Octisalate 2.5%, Octocrylene 3.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.0%, Octisalate 2.5%, Octocrylene 3.0%

Uses

• 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

Warnings

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 • Sun Protection Measures. Spending time in the sun with a broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses • 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 2.0%, Octisalate 2.5%, Octocrylene 3.0%

Inactive Ingredients

Ethylhexyl Palmitate, Mineral Oil, Isopropyl Myristate, Silica, Fragrance, Cocos Nucifera (Coconut) Oil, Polybutene, Theobroma Cacao (Cocoa) Seed Butter, Glycine Soja (Soybean) Oil, Zea Mays (Corn) Oil, Arginine, Histidine, Phenyl Trimethicone, Tartaric Acid, Daucus Carota Sativa (Carrot) Root Extract, Tocopheryl Acetate, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Beta-Carotene, Aloe Barbadensis Leaf Extract, Red 17, Yellow 11.

Stop and Ask A Doctor

if rash occurs.

Questions Or Comments?

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

Principal Display Panel

HAWAIIAN

TROPIC®

SUNSCREEN OIL SPRAY

PROTECTIVE

TANNING

ENHANCE TAN & MOISTURIZE

COCONUT OIL

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 15 UVA/UVB

WATER RESISTANT (80 MINUTES

8 FL. OZ (236 mL)

When Using This Product

keep out of eyes. Rinse with water to remove.

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 • 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

Sunscreen

Warnings

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 • Sun Protection Measures. Spending time in the sun with a broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor

Do Not Use On (Do not use on)

damaged or broken skin

Other Information

• protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 2.0%, Octisalate 2.5%, Octocrylene 3.0%

Inactive Ingredients

Ethylhexyl Palmitate, Mineral Oil, Isopropyl Myristate, Silica, Fragrance, Cocos Nucifera (Coconut) Oil, Polybutene, Theobroma Cacao (Cocoa) Seed Butter, Glycine Soja (Soybean) Oil, Zea Mays (Corn) Oil, Arginine, Histidine, Phenyl Trimethicone, Tartaric Acid, Daucus Carota Sativa (Carrot) Root Extract, Tocopheryl Acetate, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Beta-Carotene, Aloe Barbadensis Leaf Extract, Red 17, Yellow 11.

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

if rash occurs.

Questions Or Comments? (Questions or Comments?)

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

Principal Display Panel

HAWAIIAN

TROPIC®

SUNSCREEN OIL SPRAY

PROTECTIVE

TANNING

ENHANCE TAN & MOISTURIZE

COCONUT OIL

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 15 UVA/UVB

WATER RESISTANT (80 MINUTES

8 FL. OZ (236 mL)

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

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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