SPL v3
SPL
SPL Set ID 08f3b27f-b233-d406-e063-6394a90ada76
Route
TOPICAL
Published
Effective Date 2023-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Homosalate (6 g) Octocrylene (4.5 g) Octisalate
Inactive Ingredients
Alpha-tocopherol Acetate Ascorbyl Palmitate Aloe Vera Leaf Passiflora Incarnata Fruit Papaya Carrot Mango Isododecane Caprylyl Glycol Panthenol Plumeria Rubra Flower Lauryl Peg-8 Dimethicone (300 Cps) Soybean Oil Methyl Dihydroabietate Grape Seed Oil Olive Oil Guava Water Argan Oil Isobutane Diisopropyl Adipate Mineral Oil Coconut Oil Glyceryl Oleate Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-31

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

Flammable: Do not puncture or incinerate. Contents under pressure. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking. Do not store at temperatures above 120°F.

May stain some fabrics and surfaces.

Directions

• Shake well • Hold container 4 to 6 inches from the skin to apply • Spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands then apply to face. • Do not apply in windy conditions • Use in well-ventilated area • 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-sleeve shirts, pants, hats and sunglasses. • Children under 6 months: Ask a doctor.

Do Not Use

on damaged or broken skin.

Other Information



• protect the product in this container from excessive heat and direct sun

Active Ingredients

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

Inactive Ingredients

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

Questions Or Comments?

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

When Using This Product

• Keep away from face to avoid breathing it • Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor

if rash occurs

​principal Display Panel

HAWAIIAN

TROPIC(R)

SUNSCREEN DRY OIL SPRAY

PROTECTIVE

TANNING

ENHANCE TAN & MOISTURIZE

COCONUT OIL

30

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

WATER RESISTANT (80 MINUTES)

NET WT 6.0 OZ (170g)

Keep Out of Reach of Children.

If product is swallowed, get medical help or contact a Poison Control Center right away. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.


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

Flammable: Do not puncture or incinerate. Contents under pressure. Do not use in the presence of a flame or spark. Keep away from sources of ignition - No smoking. Do not store at temperatures above 120°F.

May stain some fabrics and surfaces.

Directions

• Shake well • Hold container 4 to 6 inches from the skin to apply • Spray liberally and spread evenly by hand 15 minutes before sun exposure • Do not spray directly into face. Spray on hands then apply to face. • Do not apply in windy conditions • Use in well-ventilated area • 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-sleeve 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 the product in this container from excessive heat and direct sun

Active Ingredients

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

Inactive Ingredients

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

Questions Or Comments? (Questions or Comments?)

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

When Using This Product (When using this product)

• Keep away from face to avoid breathing it • Keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

​principal Display Panel (​Principal Display Panel)

HAWAIIAN

TROPIC(R)

SUNSCREEN DRY OIL SPRAY

PROTECTIVE

TANNING

ENHANCE TAN & MOISTURIZE

COCONUT OIL

30

DERM TESTED | VEGAN

BROAD SPECTRUM SPF 30 UVA/UVB

WATER RESISTANT (80 MINUTES)

NET WT 6.0 OZ (170g)

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. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.


Advanced Ingredient Data


Raw Label Data

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