SPL v3
SPL
SPL Set ID e78c9ae0-c2ef-12ce-e053-2995a90abf1c
Route
TOPICAL
Published
Effective Date 2022-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (8.5 g) Avobenzone (2.8 g) Octisalate (4.7 g) Homosalate (9.5 g)
Inactive Ingredients
Dihexadecyl Phosphate Coco Glucoside Chlorphenesin Xanthan Gum Shea Butter Sodium Hydroxide Edetate Disodium Anhydrous Mangifera Indica Seed Panthenol Guava Plumeria Rubra Flower Mango Diisopropyl Adipate Eicosyl Povidone Acrylic Acid Water Ceteth-10 Phosphate Glycerin Benzyl Alcohol Papaya Cetostearyl Alcohol Ethylhexyl Methoxycrylene Phenoxyethanol Mica Titanium Dioxide Passiflora Incarnata Fruit Sodium Ascorbyl Phosphate Alpha-tocopherol Acetate Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-01

Description

Avobenzone 2.8%, Homosalate 9.5%, Octisalate 4.7%, Octocrylene 8.5%.

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.8%, Homosalate 9.5%, Octisalate 4.7%, Octocrylene 8.5%.

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 2.8%, Homosalate 9.5%, Octisalate 4.7%, Octocrylene 8.5%.

Inactive Ingredients

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

(Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, 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

SUNSCREEN LOTION

SHEER TOUCH

LEAVES SKIN RADIANT

ISLAND BOTANICALS

70

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 70 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 2.8%, Homosalate 9.5%, Octisalate 4.7%, Octocrylene 8.5%.

Inactive Ingredients

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

(Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, 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 (PRINCIPAL DISPLAY PANEL)

HAWAIIAN

TROPIC

SUNSCREEN LOTION

SHEER TOUCH

LEAVES SKIN RADIANT

ISLAND BOTANICALS

70

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 70 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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