SPL v3
SPL
SPL Set ID dc8ca3ed-5411-6278-e053-2995a90a0efc
Route
TOPICAL
Published
Effective Date 2022-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Octocrylene (3 g) Homosalate Octisalate
Inactive Ingredients
Cetostearyl Alcohol Glycerin Alkyl (c12-15) Benzoate Sodium Hydroxide .alpha.-tocopherol Acetate Papaya Guava Xanthan Gum Edetate Disodium Anhydrous Plumeria Rubra Flower Aloe Vera Leaf Mangifera Indica Seed Butter Diethanolamine Cetyl Phosphate Phenoxyethanol Dimethicone Coco Glucoside Ceteth-10 Phosphate Panthenol Sodium Ascorbyl Phosphate Mango Passiflora Incarnata Fruit Water Benzyl Alcohol Diisopropyl Adipate Chlorphenesin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-04-13 Until 2026-10-31

Description

Avobenzone 2.0%, Homosalate 3.0%, Octisalate 2.0%, Octocrylene 3.0% .

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.0%, Homosalate 3.0%, Octisalate 2.0%, 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.

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 2.0%, Homosalate 3.0%, Octisalate 2.0%, Octocrylene 3.0% .

Inactive Ingredients

Water, Cetearyl Alcohol, Phenoxyethanol,

Benzyl Alcohol, Glycerin, Diisopropyl Adipate, Acrylates/C12-22

Alkyl Methacrylate Copolymer, Fragrance, C12-15 Alkyl Benzoate,

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Coco-Glucoside,

Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate,

Dimethicone, Sodium Hydroxide, Xanthan Gum, Disodium EDTA,

Mangifera Indica (Mango) Seed Butter, Tocopheryl Acetate, Carica

Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit

Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia

Flower Extract, Psidium Guajava Fruit 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®

SPORT SUNSCREEN LOTION

EVERYDAY

ACTIVE

SWEAT | WATER RESISTANT

(80 MINUTES)

15

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 15 UVA/UVB

8 FL. OZ (236 mL)

When Using This Product

do not get into eyes. If contact occurs, rinse thoroughly with water. •

Stop Use and Ask A Doctor

if irritation or rash develops.

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.

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 2.0%, Homosalate 3.0%, Octisalate 2.0%, Octocrylene 3.0% .

Inactive Ingredients

Water, Cetearyl Alcohol, Phenoxyethanol,

Benzyl Alcohol, Glycerin, Diisopropyl Adipate, Acrylates/C12-22

Alkyl Methacrylate Copolymer, Fragrance, C12-15 Alkyl Benzoate,

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Coco-Glucoside,

Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate,

Dimethicone, Sodium Hydroxide, Xanthan Gum, Disodium EDTA,

Mangifera Indica (Mango) Seed Butter, Tocopheryl Acetate, Carica

Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit

Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia

Flower Extract, Psidium Guajava Fruit 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 (PRINCIPAL DISPLAY PANEL)

HAWAIIAN

TROPIC®

SPORT SUNSCREEN LOTION

EVERYDAY

ACTIVE

SWEAT | WATER RESISTANT

(80 MINUTES)

15

CRUELTY FREE | VEGAN

BROAD SPECTRUM SPF 15 UVA/UVB

8 FL. OZ (236 mL)

When Using This Product (When using this product)

do not get into eyes. If contact occurs, rinse thoroughly with water. •

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

if irritation or rash develops.

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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