DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Avobenzone (3 g) Octocrylene (10 g) Homosalate (5 g) Octisalate

Inactive Ingredients

Ceresin Ethylhexyl Palmitate Saccharin Sodium Anhydrous .alpha.-tocopherol Acetate Coconut Oil Mineral Oil Polyethylene Glycol 400 Aloe Vera Leaf Petrolatum Rice Bran Butyloctyl Salicylate Medium-chain Triglycerides Vinylpyrrolidone/eicosene Copolymer

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-09-01

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

MOISURIZES

FOR 12 HRS

50+

UVA/UVB

PROTECTION

BANANA

BOAT(R)

SPORT

ultra

BROAD SPECTRUM SPF 50+

SUNSCREEN LIP BALM

Water Resistant (80 minutes)

FREE FROM

Oxybenzone

Octinoxate

Parabens

Phthalates

NET WT. 0.15 oz. (4.25 g)

MOISURIZES

FOR 12 HRS

OXYBENZONE &

OCTINOXATE FREE

50+

UVA/UVB BROAD

SPECTRUM PROTECTION

BANANA

BOAT(R)

SPORT

ultra

TWIN PACK

SUNSCREEN LIP BALM

Water Resistant (80 minutes)

2 - 0.15oz (4.25g)

Total Net Weight - 0.3oz (8.5g)

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

MOISURIZES

FOR 12 HRS

50+

UVA/UVB

PROTECTION

BANANA

BOAT(R)

SPORT

ultra

BROAD SPECTRUM SPF 50+

SUNSCREEN LIP BALM

Water Resistant (80 minutes)

FREE FROM

Oxybenzone

Octinoxate

Parabens

Phthalates

NET WT. 0.15 oz. (4.25 g)

MOISURIZES

FOR 12 HRS

OXYBENZONE &

OCTINOXATE FREE

50+

UVA/UVB BROAD

SPECTRUM PROTECTION

BANANA

BOAT(R)

SPORT

ultra

TWIN PACK

SUNSCREEN LIP BALM

Water Resistant (80 minutes)

2 - 0.15oz (4.25g)

Total Net Weight - 0.3oz (8.5g)

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

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Raw Label Data

All Sections (JSON)

{"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": "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": "MOISURIZES FOR 12 HRS 50+ UVA/UVB PROTECTION BANANA BOAT(R) SPORT ultra BROAD SPECTRUM SPF 50+ SUNSCREEN LIP BALM Water Resistant (80 minutes) FREE FROM Oxybenzone Octinoxate Parabens Phthalates NET WT. 0.15 oz. (4.25 g) MOISURIZES FOR 12 HRS OXYBENZONE & OCTINOXATE FREE 50+ UVA/UVB BROAD SPECTRUM PROTECTION BANANA BOAT(R) SPORT ultra TWIN PACK SUNSCREEN LIP BALM Water Resistant (80 minutes) 2 - 0.15oz (4.25g) Total Net Weight - 0.3oz (8.5g)", "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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information