DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octisalate (4.5 g) Avobenzone (2.7 g) Octocrylene (6.5 g) Homosalate (9 g)

Inactive Ingredients

Water Edetate Disodium Sodium Polyacrylate (2500000 Mw) Phenoxyethanol .alpha.-tocopherol Acetate Chlorphenesin Xanthan Gum Glyceryl Monostearate Aloe Vera Leaf Cetyl Alcohol Propylene Glycol Caprylyl Glycol Vinylpyrrolidone/eicosene Copolymer Peg-100 Stearate Docosanol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2025-01-01 Until 2025-11-01

Medication Information

Purpose

Sunscreen

Description

Avobenzone 2.7%, Homosalate 9.0%,Octisalate 4.5%, Octocrylene 6.5%

Uses

•helps prevent sunburn • if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early aging caused by the sun.

Warnings

For external use only.

May stain some fabrics.

Directions

• Shake well • 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 the product in this container from excessive heat and direct sun

Active Ingredients

Avobenzone 2.7%, Homosalate 9.0%,Octisalate 4.5%, Octocrylene 6.5%

Inactive Ingredients:

Water, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Cetyl Dimethicone, Propylene Glycol, Phenoxyethanol, Caprylyl Glycol, VP/Eicosene Copolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Behenyl Alcohol, Sodium Polyacrylate, Chlorphenesin, Xanthan Gum, Disodium EDTA, Fragrance, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Questions Or Comments?

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel

BANANA

BOAT

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

OXYBENZONE FREE

WATER RESISTANT

(80 MINUTES)

10 FL OZ (295 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 aging caused by the sun.

Purpose

Sunscreen

Warnings

For external use only.

May stain some fabrics.

Directions

• Shake well • 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 the product in this container from excessive heat and direct sun

Active Ingredients

Avobenzone 2.7%, Homosalate 9.0%,Octisalate 4.5%, Octocrylene 6.5%

Inactive Ingredients:

Water, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Cetyl Dimethicone, Propylene Glycol, Phenoxyethanol, Caprylyl Glycol, VP/Eicosene Copolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Behenyl Alcohol, Sodium Polyacrylate, Chlorphenesin, Xanthan Gum, Disodium EDTA, Fragrance, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.

Questions Or Comments? (Questions or Comments?)

Call 1-800-SafeSun, Mon-Fri

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

BANANA

BOAT

SPORT

SUNSCREEN LOTION

BROAD SPECTRUM SPF 50+

50+

PROTECTS

FROM UP TO 98%

OF BURNING RAYS

OXYBENZONE FREE

WATER RESISTANT

(80 MINUTES)

10 FL OZ (295 mL)

When Using This Product (When using this product)

•keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (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

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "4.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "2.7", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM POLYACRYLATE (2500000 MW)", "unii": "05I15JNI2J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "6.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLORPHENESIN", "unii": "I670DAL4SZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL MONOSTEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "9", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "CETYL ALCOHOL", "unii": "936JST6JCN", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "VINYLPYRROLIDONE/EICOSENE COPOLYMER", "unii": "035MV9S1C3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-100 STEARATE", "unii": "YD01N1999R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DOCOSANOL", "unii": "9G1OE216XY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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 aging caused by the sun.", "Purpose": "Sunscreen", "Warnings": "For external use only. May stain some fabrics.", "Directions": "• Shake well • 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 the product in this container from excessive heat and direct sun", "Active Ingredients": "Avobenzone 2.7%, Homosalate 9.0%,Octisalate 4.5%, Octocrylene 6.5%", "Inactive Ingredients:": "Water, Glyceryl Stearate, PEG-100 Stearate, Cetyl Alcohol, Cetyl Dimethicone, Propylene Glycol, Phenoxyethanol, Caprylyl Glycol, VP/Eicosene Copolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Behenyl Alcohol, Sodium Polyacrylate, Chlorphenesin, Xanthan Gum, Disodium EDTA, Fragrance, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice.", "Questions or Comments?": "Call 1-800-SafeSun, Mon-Fri", "PRINCIPAL DISPLAY PANEL": "BANANA BOAT SPORT SUNSCREEN LOTION BROAD SPECTRUM SPF 50+ 50+ PROTECTS FROM UP TO 98% OF BURNING RAYS OXYBENZONE FREE WATER RESISTANT (80 MINUTES) 10 FL OZ (295 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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information