DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Homosalate (10 g) Octisalate (5 g) Avobenzone (2.5 g)

Inactive Ingredients

Ferric Oxide Yellow Ferric Oxide Red Ferrosoferric Oxide Meadowfoam Seed Oil Mica .alpha.-tocopherol, Dl- Soybean Oil Benzyl Benzoate Salicylic Acid Titanium Dioxide D&c Red No. 7 Garcinia Indica Seed Butter Stevia Rebaudiuna Leaf Shea Butter Benzyl Alcohol Anise Oil Sunflower Oil Lauroyl Lysine Cocoa Butter Hydrogenated Coco-glycerides Butyloctyl Salicylate Coconut Oil Candelilla Wax Castor Oil Yellow Wax Carnauba Wax Fd&c Yellow No. 5 D&c Red No. 33

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-01-22

Medication Information

Warnings and Precautions

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

Indications and Usage

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

Dosage and Administration

Apply liberally 15 minutes before sun exposire. Reapply:

after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours

Description

Avobenzone - 2.5% Octisalate - 5% Homosalate - 10%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6

Natural Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Berry Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Red 33 Lake (CI 17200), Red 7 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Summer Crush Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Beeswax, Ricinus Communis (Castor) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Titanium Dioxide (CI 77891), Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Iron Oxide (CI 77492), Iron Oxides (CI 77491), Red 7 Lake (CI 15850), Tocopherol, Iron Oxides (CI77499), Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Section 51945-4

Section 53413-1

1-800-395-1001

Section 55105-1

Avobenzone - Sunscreen

Octisalate - Sunscreen

Homosalate - Sunscreen

Section 55106-9

Avobenzone - 2.5%

Octisalate - 5%

Homosalate - 10%

Section 59845-8

Limit time in the sun, especially from 10am-2pm

Wear long sleeved shirts, pants, hats and sunglasses

Childresn under 6 months of age, ask doctor

Section 60561-8

Protect the product in this container from excessive heat and direct sun

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposire. Reapply:

after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6 (51727-6)

Natural Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Berry Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Red 33 Lake (CI 17200), Red 7 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Summer Crush Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Beeswax, Ricinus Communis (Castor) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Titanium Dioxide (CI 77891), Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Iron Oxide (CI 77492), Iron Oxides (CI 77491), Red 7 Lake (CI 15850), Tocopherol, Iron Oxides (CI77499), Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-800-395-1001

Section 55105-1 (55105-1)

Avobenzone - Sunscreen

Octisalate - Sunscreen

Homosalate - Sunscreen

Section 55106-9 (55106-9)

Avobenzone - 2.5%

Octisalate - 5%

Homosalate - 10%

Section 59845-8 (59845-8)

Limit time in the sun, especially from 10am-2pm

Wear long sleeved shirts, pants, hats and sunglasses

Childresn under 6 months of age, ask doctor

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun

Advanced Ingredient Data

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"strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SALICYLIC ACID", "unii": "O414PZ4LPZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 7", "unii": "ECW0LZ41X8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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{"34067-9": "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", "34068-7": "Apply liberally 15 minutes before sun exposire. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours", "34071-1": "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", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away", "51727-6": "Natural Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate. Berry Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Beeswax, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Red 33 Lake (CI 17200), Red 7 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140), Tocopherol, Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate. Summer Crush Inactive Ingredients: Cocos Nucifera (Coconut) Oil, Beeswax, Ricinus Communis (Castor) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Butyrospermum Parkii (Shea) Butter, Theobroma Cacao (Cocoa) Seed Butter, Butyloctyl Salicylate, Hydrogenated Coco-Glycerides, Copernicia Cerifera (Carnauba) Wax, Garcinia Indica Seed Butter, Titanium Dioxide (CI 77891), Flavor, Limnanthes Alba (Meadowfoam) Seed Oil, Benzyl Benzoate, Mica, Iron Oxide (CI 77492), Iron Oxides (CI 77491), Red 7 Lake (CI 15850), Tocopherol, Iron Oxides (CI77499), Stevia Rebaudiana Leaf/Stem Extract, Lauroyl Lysine, Glycine Soja (Soybean) Oil, Benzyl Alcohol, Benzyl Salicylate.", "53413-1": "1-800-395-1001", "55105-1": "Avobenzone - Sunscreen Octisalate - Sunscreen Homosalate - Sunscreen", "55106-9": "Avobenzone - 2.5% Octisalate - 5% Homosalate - 10%", "59845-8": "Limit time in the sun, especially from 10am-2pm Wear long sleeved shirts, pants, hats and sunglasses Childresn under 6 months of age, ask doctor", "60561-8": "Protect the product in this container from excessive heat and direct sun"}

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