SPL v4
SPL
SPL Set ID 055431a6-e9e0-99b4-e063-6394a90acb11
Route
TOPICAL
Published
Effective Date 2023-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Octisalate (3.5 g) Homosalate (4 g) Octocrylene
Inactive Ingredients
Starch, Rice Alcohol Plumeria Rubra Flower Panthenol Diisopropyl Adipate Caprylyl Glycol Corn Oil Sodium Hydroxide Alpha-tocopherol Acetate Guava Safflower Oil Phenoxyethanol Sodium Ascorbyl Phosphate Mango Papaya Glycerin Xanthan Gum Passiflora Incarnata Fruit Aloe Vera Leaf Chlorphenesin Water Edetate Disodium Carbomer Homopolymer, Unspecified Type Gluconolactone Beta Carotene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-10-01 Until 2027-08-15
Description

Avobenzone 2.0%, Homosalate 3.5%, Octisalate 2.0%, Octocrylene 4.0%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.0%, Homosalate 3.5%, Octisalate 2.0%, Octocrylene 4.0%

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 2.0%, Homosalate 3.5%, Octisalate 2.0%, Octocrylene 4.0%

Inactive Ingredients:

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

Questions Or Comments?

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

Principal Display Panel

NEW!

MORE HYDRATING

HAWAIIAN

TROPIC(R)

NON-GREASY SUNSCREEN LOTION

WEIGHTLESS

HYDRATION FACE

12HR MOISTURIZATION

30

CRUELTY FREE / VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

1.7 FL. OZ (50mL)

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.

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 2.0%, Homosalate 3.5%, Octisalate 2.0%, Octocrylene 4.0%

Inactive Ingredients:

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

Questions Or Comments? (Questions or Comments?)

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

Principal Display Panel

NEW!

MORE HYDRATING

HAWAIIAN

TROPIC(R)

NON-GREASY SUNSCREEN LOTION

WEIGHTLESS

HYDRATION FACE

12HR MOISTURIZATION

30

CRUELTY FREE / VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

1.7 FL. OZ (50mL)

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:54.986310 · Updated: 2026-03-14T23:08:21.075335