SPL v2
SPL
SPL Set ID 16b4342e-6705-ca09-e063-6294a90a947d
Route
TOPICAL
Published
Effective Date 2024-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.7 g) Octisalate (4 g) Homosalate (9 g) Octocrylene (5 g)
Inactive Ingredients
Chlorphenesin Aloe Vera Leaf Xanthan Gum Diisopropyl Adipate Glycerin Alpha-tocopherol Acetate Phenoxyethanol Dihexadecyl Phosphate Benzyl Alcohol Green Tea Leaf Mangifera Indica Seed Butter Passiflora Incarnata Fruit Water Cetostearyl Alcohol Papaya Mango Guava Sodium Hydroxide Panthenol Ceteth-10 Phosphate Plumeria Rubra Flower Sodium Ascorbyl Phosphate Propylene Glycol Coco Glucoside Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-01-05 Until 2026-10-31

Description

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

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 2 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 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeved 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 2.7%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

Inactive Ingredients

Water, Diisopropyl Adipate, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dicetyl Phosphate, Ceteth-10 Phosphate, Coco-Glucoside, Chlorphenesin, Fragrance, Xanthan Gum, Sodium Hydroxide, Camellia Sinensis Leaf Extract, Disodium EDTA, Tocopheryl Acetate, Mangifera Indica (Mango) Seed Butter, Psidium Guajava Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate.

Questions Or Comments?

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

Principal Display Panel

HAWAIIAN

TROPIC®

SUNSCREEN LOTION

SKIN DEFENSE

PROTECTS AGAINST UVA SKIN AGING

GREEN TEA EXTRACT

50

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 50 UVA/UVB

WATER RESISTANT (80 MINUTES)

6 FL. OZ (177 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 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 2 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 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses • 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 2.7%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

Inactive Ingredients

Water, Diisopropyl Adipate, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dicetyl Phosphate, Ceteth-10 Phosphate, Coco-Glucoside, Chlorphenesin, Fragrance, Xanthan Gum, Sodium Hydroxide, Camellia Sinensis Leaf Extract, Disodium EDTA, Tocopheryl Acetate, Mangifera Indica (Mango) Seed Butter, Psidium Guajava Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate.

Questions Or Comments? (Questions or Comments?)

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

Principal Display Panel

HAWAIIAN

TROPIC®

SUNSCREEN LOTION

SKIN DEFENSE

PROTECTS AGAINST UVA SKIN AGING

GREEN TEA EXTRACT

50

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 50 UVA/UVB

WATER RESISTANT (80 MINUTES)

6 FL. OZ (177 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 swallowed, get medical help or contact a Poison Control Center right away.


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Raw Label Data

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