SPL v4
SPL
SPL Set ID 05ba5966-f0ff-5360-e063-6294a90a0fc9
Route
TOPICAL
Published
Effective Date 2023-09-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

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 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

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, 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.

Stop and Ask A Doctor

if rash occurs.

Questions Or Comments?

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

Principal Display Panel

HAWAIIAN

TROPIC(R)

SUNSCREEN LOTION

SHEER TOUCH

LEAVES SKIN RADIANT

ISLAND BOTANICALS

50

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 50 UVA/UVB

WATER RESISTANT (80 MINUTES)

8 FL. OZ (236 mL)

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

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 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

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, 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.

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

Principal Display Panel

HAWAIIAN

TROPIC(R)

SUNSCREEN LOTION

SHEER TOUCH

LEAVES SKIN RADIANT

ISLAND BOTANICALS

50

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 50 UVA/UVB

WATER RESISTANT (80 MINUTES)

8 FL. OZ (236 mL)

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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