SPL v3
SPL
SPL Set ID dc8e2ee8-e67f-ef5d-e053-2995a90a1520
Route
TOPICAL
Published
Effective Date 2022-04-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.7 g) Homosalate (9 g) Octocrylene (5 g) Octisalate (4 g)
Inactive Ingredients
Xanthan Gum Mango Panthenol Sodium Hydroxide Edetate Disodium Anhydrous Phenoxyethanol Passiflora Incarnata Fruit Ceteth-10 Phosphate Papaya Water Cetostearyl Alcohol Benzyl Alcohol Alkyl (c12-15) Benzoate Coco Glucoside Chlorphenesin Dimethicone Mangifera Indica Seed Butter Plumeria Rubra Flower Guava Aloe Vera Leaf Sodium Ascorbyl Phosphate Diisopropyl Adipate Dihexadecyl Phosphate .alpha.-tocopherol Acetate Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-13

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, Fragrance, C12-15 Alkyl Benzoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Chlorphenesin, Xanthan Gum, Dimethicone, Sodium Hydroxide, 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)

50

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 50 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 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, Fragrance, C12-15 Alkyl Benzoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Chlorphenesin, Xanthan Gum, Dimethicone, Sodium Hydroxide, 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)

50

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 50 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.


Advanced Ingredient Data


Raw Label Data

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