DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (7.5 g) Avobenzone (3 g) Octisalate (5 g)

Inactive Ingredients

Cetearyl Alcohol Acrylates Crosspolymer-4 Phenoxyethanol Sodium Hydroxide Ethylhexylglycerin Panthenol Ethylhexyl Stearate Glyceryl Stearate Aqua Acrylates/methoxy Peg-10 Maleate/styrene Copolymer Parfumidine

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-05

Medication Information

Description

Aqua , Ethylhexyl Stearate , Phenoxyethanol , Glyceryl Stearate , Acrylates Copolymer , Cetearyl Alcohol , Styrene/Acrylates Copolymer , Parfum , Ethylhexylglycerin ,Panthenol ,Tocopheryl Acetate.

Section 51945-4

Warnings

For external use only.

Do not use on damaged or broken skin.

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.

Directions

Apply generously 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 board 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.

Active Ingredients

Avobenzone 3.0%

Octisalate 5.0%

Octinoxate 7.5%

Other Safety Information

Protect this Product from excessive heat and direct sun

May stain some fabrics

Keep Out Reach of Children

If Product is swallowed , get medical help or contact a Poison Control Center right away.

Inactive Ingredient Section

Aqua , Ethylhexyl Stearate , Phenoxyethanol , Glyceryl Stearate , Acrylates Copolymer , Cetearyl Alcohol , Styrene/Acrylates Copolymer , Parfum , Ethylhexylglycerin ,Panthenol ,Tocopheryl Acetate.

Structured Label Content

Section 51945-4 (51945-4)

Warnings (WARNINGS)

For external use only.

Do not use on damaged or broken skin.

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.

Directions

Apply generously 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 board 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.

Active Ingredients (ACTIVE INGREDIENTS)

Avobenzone 3.0%

Octisalate 5.0%

Octinoxate 7.5%

Other Safety Information (OTHER SAFETY INFORMATION)

Protect this Product from excessive heat and direct sun

May stain some fabrics

Keep Out Reach of Children (Keep out reach of children)

If Product is swallowed , get medical help or contact a Poison Control Center right away.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Aqua , Ethylhexyl Stearate , Phenoxyethanol , Glyceryl Stearate , Acrylates Copolymer , Cetearyl Alcohol , Styrene/Acrylates Copolymer , Parfum , Ethylhexylglycerin ,Panthenol ,Tocopheryl Acetate.

Advanced Ingredient Data

[{"name": "CETEARYL ALCOHOL", "unii": "2DMT128M1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACRYLATES CROSSPOLYMER-4", "unii": "GEV2EL4D9G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PANTHENOL", "unii": "WV9CM0O67Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "7.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ETHYLHEXYL STEARATE", "unii": "EG3PA2K3K5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERYL STEARATE", "unii": "230OU9XXE4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AQUA", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ACRYLATES/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER", "unii": "39DK5WQ2PR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PARFUMIDINE", "unii": "A2Q2LHC6MA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"WARNINGS": "For external use only. Do not use on damaged or broken skin. 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.", "Directions": "Apply generously 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 board 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.", "ACTIVE INGREDIENTS": "Avobenzone 3.0% Octisalate 5.0% Octinoxate 7.5%", "OTHER SAFETY INFORMATION": "Protect this Product from excessive heat and direct sun May stain some fabrics", "Keep out reach of children": "If Product is swallowed , get medical help or contact a Poison Control Center right away.", "INACTIVE INGREDIENT SECTION": "Aqua , Ethylhexyl Stearate , Phenoxyethanol , Glyceryl Stearate , Acrylates Copolymer , Cetearyl Alcohol , Styrene/Acrylates Copolymer , Parfum , Ethylhexylglycerin ,Panthenol ,Tocopheryl Acetate."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information