SPL v4
SPL
SPL Set ID afff2e48-552c-b84c-e053-2995a90ac1e6
Route
TOPICAL
Published
Effective Date 2020-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (6 g) Avobenzone (2 g) Homosalate (4.5 g) Octisalate
Inactive Ingredients
Mineral Oil Grape Seed Oil Water Lauryl Peg/ppg-18/18 Methicone Ascorbyl Palmitate Coconut Oil Olive Oil .alpha.-tocopherol Acetate Argan Oil Panthenol Mango Passiflora Incarnata Fruit Guava Alcohol Methyl Dihydroabietate Isododecane Diisopropyl Adipate Caprylyl Glycol Papaya Plumeria Rubra Flower Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-09-25 Until 2025-10-21

Description

Avobenzone 2.0%, Homosalate 6.0%, Octisalate 4.5%, Octocrylene 6.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.0%, Homosalate 6.0%, Octisalate 4.5%, Octocrylene 6.0%

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

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 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 longsleeved 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 6.0%, Octisalate 4.5%, Octocrylene 6.0%

Inactive Ingredients

Alcohol Denat., Isododecane, Diisopropyl Adipate, Mineral Oil, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Lauryl PEG-8 Dimethicone, Caprylyl Glycol, Methyl Dihydroabietate, Fragrance, Tocopheryl Acetate, Ascorbyl Palmitate, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Olea Europaea (Olive) Fruit Oil, Argania Spinosa Kernel Oil, Water, Panthenol, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Aloe Barbadensis Leaf Extract

Primary Display Panel

NEW

HAWAIIAN

Tropic (R)

Silk

HYDRATION (R)

Dry Oil Sunscreen

WEIGHTLESS OIL

30

BROAD SPECTRUM SPF 30 UVA/UVB

Coconut & Argan Oil

Non-greasy

Reef Friendly*

5 FL. OZ. (148 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.

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

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 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 longsleeved 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 (Other information)

Protect this product from excessive heat and direct sun

Active Ingredients (Active ingredients)

Avobenzone 2.0%, Homosalate 6.0%, Octisalate 4.5%, Octocrylene 6.0%

Inactive Ingredients

Alcohol Denat., Isododecane, Diisopropyl Adipate, Mineral Oil, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Lauryl PEG-8 Dimethicone, Caprylyl Glycol, Methyl Dihydroabietate, Fragrance, Tocopheryl Acetate, Ascorbyl Palmitate, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Olea Europaea (Olive) Fruit Oil, Argania Spinosa Kernel Oil, Water, Panthenol, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Aloe Barbadensis Leaf Extract

Primary Display Panel

NEW

HAWAIIAN

Tropic (R)

Silk

HYDRATION (R)

Dry Oil Sunscreen

WEIGHTLESS OIL

30

BROAD SPECTRUM SPF 30 UVA/UVB

Coconut & Argan Oil

Non-greasy

Reef Friendly*

5 FL. OZ. (148 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.

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

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