SPL v7
SPL
SPL Set ID 0f772b91-e67b-46cf-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2.5 g) Octocrylene (8 g) Oxybenzone (3.5 g)
Inactive Ingredients
Caprylyl Glycol Edetate Disodium Sodium Ascorbyl Phosphate Benzyl Alcohol Methylparaben Water Hydrogenated Methyl Abietate Aloe Vera Leaf Butyloctyl Salicylate Ethylhexyl Palmitate Hydrated Silica Cyclomethicone 5 Cyclomethicone 6 Sodium Chloride Yellow Wax Microcrystalline Wax High Density Polyethylene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-02-19 Until 2027-07-01

Description

Avobenzone 2.5%, Octocrylene 8.0%, Oxybenzone 3.5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.5%, Octocrylene 8.0%, Oxybenzone 3.5%

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.

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, regulrly 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 this product from excessive heat and direct sun

Active Ingredients

Avobenzone 2.5%, Octocrylene 8.0%, Oxybenzone 3.5%

Inactive Ingredients

Water, Hydrogenated Polyisobutene, Lauryl PEG-8 Dimethicone, Butyloctyl Salicylate, Ethylhexyl Palmitate, Hydrated Silica, Cyclopentasiloxane, Cyclohexasiloxane, Sodium Chloride, Benzyl Alcohol, Beeswax, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Methylparaben, Microcrystalline Wax, Polyethylene, Caprylyl Glycol, Propylparaben, Disodium EDTA, Stearoxy Dimethicone, Methyl Dihydroabietate, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Primary Display Panel

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 100

100

CLINICALLY PROVEN

UVA/UVB PROTECTIO

SUPERIOR ENDURANCE

VS. SWEAT & WATER

Water Resistant

(80 Minutes)

4 FL. OZ. (118mL)

Questions Or Comments?

Call 1 800 SafeSun, 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, regulrly 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 this product from excessive heat and direct sun

Active Ingredients

Avobenzone 2.5%, Octocrylene 8.0%, Oxybenzone 3.5%

Inactive Ingredients (Inactive ingredients)

Water, Hydrogenated Polyisobutene, Lauryl PEG-8 Dimethicone, Butyloctyl Salicylate, Ethylhexyl Palmitate, Hydrated Silica, Cyclopentasiloxane, Cyclohexasiloxane, Sodium Chloride, Benzyl Alcohol, Beeswax, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Methylparaben, Microcrystalline Wax, Polyethylene, Caprylyl Glycol, Propylparaben, Disodium EDTA, Stearoxy Dimethicone, Methyl Dihydroabietate, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Primary Display Panel

BANANA

BOAT®

SPORT

ultra

SUNSCREEN LOTION

BROAD SPECTRUM SPF 100

100

CLINICALLY PROVEN

UVA/UVB PROTECTIO

SUPERIOR ENDURANCE

VS. SWEAT & WATER

Water Resistant

(80 Minutes)

4 FL. OZ. (118mL)

Questions Or Comments? (Questions or Comments?)

Call 1 800 SafeSun, 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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