SPL v2
SPL
SPL Set ID 0918fdd3-cffb-78e9-e063-6394a90ad5c7
Route
TOPICAL
Published
Effective Date 2023-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (3 g) Octisalate (2 g) Avobenzone Octocrylene
Inactive Ingredients
Plumeria Rubra Flower Sodium Ascorbyl Phosphate Water Phenoxyethanol Benzyl Alcohol Diisopropyl Adipate Ceteth-10 Phosphate Dihexadecyl Phosphate Xanthan Gum Alpha-tocopherol Acetate Mangifera Indica Seed Butter Papaya Mango Guava Panthenol Aloe Vera Leaf Shea Butter Coco Glucoside Titanium Dioxide Chlorphenesin Sodium Hydroxide Edetate Disodium Passiflora Incarnata Fruit Cetostearyl Alcohol Mica Glycerin

Identifiers & Packaging

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

Description

Avobenzone 2.0%, Homosalate 3.0%, Octisalate 2.0%, Octocrylene 3.0%.

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.0%, Homosalate 3.0%, Octisalate 2.0%, Octocrylene 3.0%.

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 2.0%, Homosalate 3.0%, Octisalate 2.0%, Octocrylene 3.0%.

Inactive Ingredients

Water, Cetearyl Alcohol, Phenoxyethanol, Mica, Benzyl Alcohol, Diisopropyl Adipate, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Coco-Glucoside, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Sodium Hydroxide, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Disodium EDTA, Tocopheryl Acetate, Mangifera Indica (Mango) Seed Butter, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Psidium Guajava Fruit Extract, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate, Titanium Dioxide.

Stop and Ask A Doctor

if rash occurs.

Pricipal Display Panel

HAWAIIAN

TROPIC(R)

SUNSCREEN LOTION

SHEER TOUCH

LEAVES SKIN RADIANT

ISLAND BOTANICALS

15

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 15 UVA/UVB

WATER RESISTANT (80 MINUTES)

8 FL. OZ (236 mL)

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

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 2.0%, Homosalate 3.0%, Octisalate 2.0%, Octocrylene 3.0%.

Inactive Ingredients

Water, Cetearyl Alcohol, Phenoxyethanol, Mica, Benzyl Alcohol, Diisopropyl Adipate, Glycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Coco-Glucoside, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Sodium Hydroxide, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Disodium EDTA, Tocopheryl Acetate, Mangifera Indica (Mango) Seed Butter, Plumeria Acutifolia Flower Extract, Passiflora Incarnata Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit 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.

Pricipal Display Panel (PRICIPAL DISPLAY PANEL)

HAWAIIAN

TROPIC(R)

SUNSCREEN LOTION

SHEER TOUCH

LEAVES SKIN RADIANT

ISLAND BOTANICALS

15

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 15 UVA/UVB

WATER RESISTANT (80 MINUTES)

8 FL. OZ (236 mL)

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.


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Raw Label Data

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