SPL v4
SPL
SPL Set ID c794592c-d24e-4530-e053-2995a90a7e4d
Route
TOPICAL
Published
Effective Date 2021-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (10 g) Homosalate (3 g) Avobenzone (5 g) Octisalate
Inactive Ingredients
Saccharin Sodium Anhydrous .alpha.-tocopherol Acetate Coconut Oil Aloe Vera Leaf Medium-chain Triglycerides Ethylhexyl Palmitate Polyethylene Glycol 400 Rice Bran Mineral Oil Ceresin Vinylpyrrolidone/eicosene Copolymer Butyloctyl Salicylate Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-09-01

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

Purpose

Sunscreen Agent


Medication Information

Purpose

Sunscreen Agent

Description

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

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.

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 • after eating or drinking • 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 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

Inactive Ingredients

Caprylic/Capric Triglyceride, Ozokerite, Petrolatum, Ethylhexyl Palmitate, VP/Eicosene Copolymer, Butyloctyl Salicylate, PEG-8, Oryza Sativa (Rice) Bran Wax, Flavor, Sodium Saccharin, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Mineral Oil, Aloe Barbadensis Leaf Extract.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

MOISTURIZES

FOR 12 HRS

BANANA

BOAT®

45

UVA/UVB

PROTECTION

BROAD SPECTRUM SPF 45

Sunscreen

LIP BALM

Water Resistent (80 minutes)

with ALOE VERA

& VITAMIN E

FREE FROM

Oxybenzone

Octinoxate

NET WT. 0.15 oz. (4.25 g)

BANANA

BOAT®

Sunscreen

LIP BALM

45

UVA/UVB BROAD SPECTRUM SPF 45

with ALOE VERA & VITAMIN E

Water Resistent (80 minutes)

BANANA

BOAT®

Sunscreen

LIP BALM

45

UVA/UVB BROAD SPECTRUM SPF 45

with ALOE VERA & VITAMIN E

NET WT 0.15 OZ (4.25 g) PEEL HERE

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 Agent

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 • after eating or drinking • 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 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 10.0%

Inactive Ingredients

Caprylic/Capric Triglyceride, Ozokerite, Petrolatum, Ethylhexyl Palmitate, VP/Eicosene Copolymer, Butyloctyl Salicylate, PEG-8, Oryza Sativa (Rice) Bran Wax, Flavor, Sodium Saccharin, Tocopheryl Acetate, Cocos Nucifera (Coconut) Oil, Mineral Oil, Aloe Barbadensis Leaf Extract.

Questions Or Comments? (Questions or comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

MOISTURIZES

FOR 12 HRS

BANANA

BOAT®

45

UVA/UVB

PROTECTION

BROAD SPECTRUM SPF 45

Sunscreen

LIP BALM

Water Resistent (80 minutes)

with ALOE VERA

& VITAMIN E

FREE FROM

Oxybenzone

Octinoxate

NET WT. 0.15 oz. (4.25 g)

BANANA

BOAT®

Sunscreen

LIP BALM

45

UVA/UVB BROAD SPECTRUM SPF 45

with ALOE VERA & VITAMIN E

Water Resistent (80 minutes)

BANANA

BOAT®

Sunscreen

LIP BALM

45

UVA/UVB BROAD SPECTRUM SPF 45

with ALOE VERA & VITAMIN E

NET WT 0.15 OZ (4.25 g) PEEL HERE

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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