SPL v3
SPL
SPL Set ID 77cdd346-d273-ed66-e053-2991aa0ae31d
Route
TOPICAL
Published
Effective Date 2018-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Octisalate (4 g) Homosalate (9 g) Octocrylene (5 g)
Inactive Ingredients
Coco Glucoside Cetostearyl Alcohol Dimethicone Dihexadecyl Phosphate .alpha.-tocopherol Acetate Aloe Vera Leaf Plumeria Rubra Flower Mango Carica Papaya Whole Alkyl (c12-15) Benzoate Phenethyl Benzoate Caprylyl Glycol Glycerin Benzyl Alcohol Ceteth-10 Phosphate Sodium Ascorbyl Phosphate Paraffin Chlorphenesin Sodium Hydroxide Camellia Sinensis Whole Xanthan Gum Psidium Guajava Whole Passiflora Incarnata Fruit Water Butyloctyl Salicylate Polymethylsilsesquioxane (11 Microns) Diisopropyl Adipate Vinylpyrrolidone/eicosene Copolymer Propylene Glycol Edetic Acid Poly(methyl Methacrylate; 450000 Mw) Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Phenoxyethanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-10-11 Until 2026-10-31

Description

Avobenzone 3%, Homosalate 9%, Octisalate 4%, Octocrylene 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3%, Homosalate 9%, Octisalate 4%, Octocrylene 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

50

SPF 50 BROAD SPECTRUM

UVA & UVB PROTECTION

lightweight

moisturing formula

with green tea extract

6 FL. OZ (177 mL)

Warnings

For external use only

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 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 3%, Homosalate 9%, Octisalate 4%, Octocrylene 5%

Inactive Ingredient

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. May stain some fabrics.


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

50

SPF 50 BROAD SPECTRUM

UVA & UVB PROTECTION

lightweight

moisturing formula

with green tea extract

6 FL. OZ (177 mL)

Purpose

Sunscreen

Warnings

For external use only

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 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 3%, Homosalate 9%, Octisalate 4%, Octocrylene 5%

Inactive Ingredient

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. May stain some fabrics.


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