SPL v3
SPL
SPL Set ID 767accea-c5b2-32dc-e053-2991aa0a3338
Route
TOPICAL
Published
Effective Date 2018-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (4.5 g) Avobenzone (3 g) Octisalate (6 g) Homosalate
Inactive Ingredients
Paraffin Xanthan Gum Aloe Vera Leaf Vinylpyrrolidone/eicosene Copolymer Water Propylene Glycol Carica Papaya Whole Plumeria Rubra Flower Ceteth-10 Phosphate Diisopropyl Adipate Phenethyl Benzoate Phenoxyethanol Caprylyl Glycol Alkyl (c12-15) Benzoate Butyloctyl Salicylate Cetostearyl Alcohol Chlorphenesin Sodium Hydroxide Edetic Acid .alpha.-tocopherol Acetate Sodium Ascorbyl Phosphate Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Passiflora Incarnata Flower Polymethylsilsesquioxane (11 Microns) Dimethicone Glycerin Benzyl Alcohol Coco Glucoside Poly(methyl Methacrylate; 450000 Mw) Guava Mango Green Tea Leaf Dihexadecyl Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-10-15 Until 2026-10-31

Description

Avobenzone 3%, Homosalate 6%, Octisalate 4.5%, Octocrylene 4.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 6%, Octisalate 4.5%, Octocrylene 4.5%

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

Section 51945-4

HAWAIIAN

Tropic(R)

AntiOxidant+

SUNSCREEN LOTION

Helps prevent skin damage

& skin aging from the sun

30

SPF 30 BROAD SPECTRUM

UVA & UVB PROTECTION

light weight

moisturizing formula

with green tea extract

6 FL. OZ (177 mL)

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 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 Infromation

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3%, Homosalate 6%, Octisalate 4.5%, Octocrylene 4.5%

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cetearyl Alcohol, Diisopropyl Adipate, Phenethyl Benzoate, Polymethyl Methacrylate, Polymethylsilsesquioxane, Phenoxyethanol, Caprylyl Glycol, VP/Eicosene Copolymer, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Coco-Glucoside, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Sodium Hydroxide, Camellia Sinensis Leaf Extract, Disodium EDTA, Paraffin, Xanthan Gum, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower

Extract, Psidium Guajava Fruit Extract.

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 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

Section 51945-4 (51945-4)

HAWAIIAN

Tropic(R)

AntiOxidant+

SUNSCREEN LOTION

Helps prevent skin damage

& skin aging from the sun

30

SPF 30 BROAD SPECTRUM

UVA & UVB PROTECTION

light weight

moisturizing formula

with green tea extract

6 FL. OZ (177 mL)

Purpose

Sunscreen

Warnings

For external use only

May Stain (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 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 Infromation

protect this product from excessive heat and direct sun

Active Ingredients

Avobenzone 3%, Homosalate 6%, Octisalate 4.5%, Octocrylene 4.5%

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cetearyl Alcohol, Diisopropyl Adipate, Phenethyl Benzoate, Polymethyl Methacrylate, Polymethylsilsesquioxane, Phenoxyethanol, Caprylyl Glycol, VP/Eicosene Copolymer, Benzyl Alcohol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Dimethicone, Glycerin, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Coco-Glucoside, Chlorphenesin, Ceteth-10 Phosphate, Dicetyl Phosphate, Sodium Hydroxide, Camellia Sinensis Leaf Extract, Disodium EDTA, Paraffin, Xanthan Gum, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower

Extract, Psidium Guajava Fruit Extract.

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 swallowed, get medical help or contact a Poison Control Center right away.


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Raw Label Data

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