053e76f0-8ca0-645d-e063-6394a90a01d2

SPL v4
SPL
SPL Set ID 053e76f0-8ca0-645d-e063-6394a90a01d2
Route
topical
Published
Effective Date 2023-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (2.7 g) octisalate (4.5 g) octocrylene (5.2 g)
Inactive Ingredients
passiflora incarnata fruit chlorphenesin xanthan gum sodium ascorbyl phosphate water starch, rice diisopropyl adipate dehydrated alcohol glycerin phenoxyethanol aloe vera leaf guava papaya gluconolactone corn oil edetate disodium beta carotene carbomer homopolymer, unspecified type caprylyl glycol alpha-tocopherol acetate safflower oil plumeria rubra flower sodium hydroxide panthenol mango

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-10-01 Until 2028-01-31

Purpose

Sunscreen

Description

Avobenzone 2.7%, Octisalate 4.5%, Octocrylene 5.2%


Medication Information

Warnings

For external use only.

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

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 value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear longsleeved shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Carthamus Tinctorius (Safflower) Seed Oil, Diisopropyl Adipate, Oryza Sativa (Rice) Starch, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Alcohol Denat., Phenoxyethanol, Carbomer, Caprylyl Glycol, Sodium Hydroxide, Chlorphenesin, Fragrance, Gluconolactone, Xanthan Gum, Disodium EDTA, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice, Zea Mays (Corn) Oil, Sodium Ascorbyl Phosphate, Beta-Carotene, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract

Description

Avobenzone 2.7%, Octisalate 4.5%, Octocrylene 5.2%

Principal Display Panel

HAWAIIAN TROPIC

SUNSCREEN LOTION

WEIGHTLESS

HYDRATION

12HR MOISTURIZATION*

ISLAND BOTANICALS

50

DERM TESYTED

BROAD SPECTRUM SPF 50 UVA/UVB

WATER RESISTANT (80 MINUTES)

6 FL. OZ. (177 mL)

Do Not Use

on damaged or broken skin.

Active Ingredients

Avobenzone 2.7%, Octisalate 4.5%, Octocrylene 5.2%

Questions Or Comments?

1-800-NO UV RAY, Mon-Fri

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. • May stain some fabrics and surfaces.


Structured Label Content

Warnings

For external use only.

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

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 value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear longsleeved shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Water, Carthamus Tinctorius (Safflower) Seed Oil, Diisopropyl Adipate, Oryza Sativa (Rice) Starch, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Alcohol Denat., Phenoxyethanol, Carbomer, Caprylyl Glycol, Sodium Hydroxide, Chlorphenesin, Fragrance, Gluconolactone, Xanthan Gum, Disodium EDTA, Tocopheryl Acetate, Panthenol, Aloe Barbadensis Leaf Juice, Zea Mays (Corn) Oil, Sodium Ascorbyl Phosphate, Beta-Carotene, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract

Principal Display Panel

HAWAIIAN TROPIC

SUNSCREEN LOTION

WEIGHTLESS

HYDRATION

12HR MOISTURIZATION*

ISLAND BOTANICALS

50

DERM TESYTED

BROAD SPECTRUM SPF 50 UVA/UVB

WATER RESISTANT (80 MINUTES)

6 FL. OZ. (177 mL)

Do Not Use (Do not use)

on damaged or broken skin.

Active Ingredients

Avobenzone 2.7%, Octisalate 4.5%, Octocrylene 5.2%

Questions Or Comments? (Questions or Comments?)

1-800-NO UV RAY, Mon-Fri

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. • May stain some fabrics and surfaces.


Advanced Ingredient Data


Raw Label Data

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