SPL v6
SPL
SPL Set ID 8a1eefa6-619e-5d02-e053-2995a90a3d75
Route
TOPICAL
Published
Effective Date 2019-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (4 g) Avobenzone (3 g) Homosalate (9 g) Octocrylene (5 g)
Inactive Ingredients
Cetostearyl Alcohol Chlorphenesin Polymethylsilsesquioxane (11 Microns) Ethylhexylglycerin Coco Glucoside Sodium Hydroxide Sodium Ascorbyl Phosphate Aloe Vera Leaf Silicon Dioxide Glycerin Phenoxyethanol Diisopropyl Adipate Starch, Tapioca Caprylyl Glycol Panthenol Water Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Ceteth-10 Phosphate Dihexadecyl Phosphate Xanthan Gum Edetic Acid .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-05-30 Until 2026-12-01

Description

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

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 • Children under 6 months: Ask a doctor • 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

Do Not Use

on damaged or broken skin

Active Ingredient

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Diisopropyl Adipate, Silica, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Tapioca Starch, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexlyglycerin, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Chlorphenesin, Xanthan Gum, Sodium Hydroxide, Disodium EDTA, Fragrance, Polymethylsilsesquioxane, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Panthenol, Aloe Barbadensis Leaf Juice

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA BOAT®

Light as air

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

Weightless

Protection

ABSORBS QUICKLY &

NON-GREASY

Water Resistant

(80 Minutes)

6 FL.OZ. (177 mL)

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 • Children under 6 months: Ask a doctor • 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

Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient

Avobenzone 3.0%, Homosalate 9.0%, Octisalate 4.0%, Octocrylene 5.0%

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Diisopropyl Adipate, Silica, Cetearyl Alcohol, Glycerin, Phenoxyethanol, Tapioca Starch, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Caprylyl Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylhexlyglycerin, Ceteth-10 Phosphate, Dicetyl Phosphate, Coco-Glucoside, Chlorphenesin, Xanthan Gum, Sodium Hydroxide, Disodium EDTA, Fragrance, Polymethylsilsesquioxane, Tocopheryl Acetate, Sodium Ascorbyl Phosphate, Panthenol, Aloe Barbadensis Leaf Juice

Questions Or Comments? (Questions or Comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA BOAT®

Light as air

SUNSCREEN LOTION

UVA/UVB BROAD SPECTRUM SPF 50+

50+

Weightless

Protection

ABSORBS QUICKLY &

NON-GREASY

Water Resistant

(80 Minutes)

6 FL.OZ. (177 mL)

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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