05b7aa44-cf8f-d77a-e063-6394a90a850b

SPL v8
SPL
SPL Set ID 05b7aa44-cf8f-d77a-e063-6394a90a850b
Route
topical
Published
Effective Date 2023-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
homosalate (7 g) avobenzone (2.2 g) octocrylene (4.2 g)
Inactive Ingredients
glycerin coco glucoside shea butter mango plumeria rubra flower ceteth-10 phosphate diisopropyl adipate phenoxyethanol mica mangifera indica seed butter sodium hydroxide cetostearyl alcohol chlorphenesin xanthan gum papaya dihexadecyl phosphate edetate disodium benzyl alcohol panthenol sodium ascorbyl phosphate water titanium dioxide alpha-tocopherol acetate passiflora incarnata fruit aloe vera leaf guava

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-10-01 Until 2027-10-01
Purpose

Sunscreen

Description

Avobenzone 2.2%, Homosalate 7.0%, Octocrylene 4.2% .

Medication Information

Warnings

For external use only.

May stain some fabrics and surfaces

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 two 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 long-sleeved 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, Diisopropyl Adipate, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Mica, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Chlorphenesin, Xanthan Gum, Sodium Hydroxide, Butyrospermum Parkii (Shea) Butter, Disodium EDTA, Tocopheryl Acetate, Mangifera Indica (Mango) Seed Butter, 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, Titanium Dioxide.

Description

Avobenzone 2.2%, Homosalate 7.0%, Octocrylene 4.2% .

Principal Display Panel

HAWAIIAN

TROPIC(R)

SUNSCREEN LOTION

SHEER TOUCH

LEAVES SKIN RADIANT

ISLAND BOTANICALS

30

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

WATER RESISTANT (80 MINUTES)

8 FL. OZ (236 mL)

HAWAIIAN

TROPIC(R)

SUNSCREEN LOTION

SHEER TOUCH

LEAVES SKIN RADIANT

ISLAND BOTANICALS

30

VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

2 FL. OZ (59 mL)

HAWAIIAN

TROPIC(R)

SUNSCREEN LOTION

SHEER TOUCH

LEAVES SKIN RADIANT

ISLAND BOTANICALS

30

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

WATER RESISTANT (80 MINUTES)

10.8 FL. OZ (319 mL)

2 PACK

HAWAIIAN

TROPIC(R)

SUNSCREEN LOTION

SHEER TOUCH

LEAVES SKIN RADIANT

ISLAND BOTANICALS

30

VEGAN | DERM TESTED

BROAD SPECTRUM SPF 30 UVA/UVB

WATER RESISTANT (80 MINUTES)

2-8 FL. OZ (236 mL) BOTTLES - TOTAL 16 FL. OZ. (472 mL)

Do Not Use

on damaged or broken skin

Active Ingredients

Avobenzone 2.2%, Homosalate 7.0%, Octocrylene 4.2% .

Stop and Ask A Doctor

if rash occurs.

Questions Or Comments?

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

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

Warnings

For external use only.

May stain some fabrics and surfaces

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 two 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 long-sleeved 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, Diisopropyl Adipate, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Mica, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Chlorphenesin, Xanthan Gum, Sodium Hydroxide, Butyrospermum Parkii (Shea) Butter, Disodium EDTA, Tocopheryl Acetate, Mangifera Indica (Mango) Seed Butter, 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, Titanium Dioxide.

Principal Display Panel

HAWAIIAN

TROPIC(R)

SUNSCREEN LOTION

SHEER TOUCH

LEAVES SKIN RADIANT

ISLAND BOTANICALS

30

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

WATER RESISTANT (80 MINUTES)

8 FL. OZ (236 mL)

HAWAIIAN

TROPIC(R)

SUNSCREEN LOTION

SHEER TOUCH

LEAVES SKIN RADIANT

ISLAND BOTANICALS

30

VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

2 FL. OZ (59 mL)

HAWAIIAN

TROPIC(R)

SUNSCREEN LOTION

SHEER TOUCH

LEAVES SKIN RADIANT

ISLAND BOTANICALS

30

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

WATER RESISTANT (80 MINUTES)

10.8 FL. OZ (319 mL)

2 PACK

HAWAIIAN

TROPIC(R)

SUNSCREEN LOTION

SHEER TOUCH

LEAVES SKIN RADIANT

ISLAND BOTANICALS

30

VEGAN | DERM TESTED

BROAD SPECTRUM SPF 30 UVA/UVB

WATER RESISTANT (80 MINUTES)

2-8 FL. OZ (236 mL) BOTTLES - TOTAL 16 FL. OZ. (472 mL)

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredients

Avobenzone 2.2%, Homosalate 7.0%, Octocrylene 4.2% .

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

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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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:29.116330 · Updated: 2026-03-14T23:12:02.945870