DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Homosalate (7 g) Octocrylene (5 g) Octisalate (3 g) Avobenzone

Inactive Ingredients

Butyloctyl Salicylate Sunflower Oil Orange Terpenes Pogostemon Cablin Oil Ethylhexyl Palmitate Tocopherol Silicon Dioxide Coconut Oil Citrus Limon (lemon) Peel Oil Starch, Tapioca Aniba Rosaeodora Wood Paraffin Soybean Oil Ocimum Basilicum (basil) Oil Eucalyptus Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-12-03

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

Indications and Usage

Stop use and ask a doctor if rash occurs

Dosage and Administration

Apply generously and evenly 15 minutes before sun exposure

Reapply (will vary depending on WR)

after XX minutes of swimming or sweating

Immediately after towel drying

at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

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

Description

Homosalate 7.0%, Octocrylene 7.0%, Octisalate 5.0%, Avobenzone 3.0%

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.

Section 51727-6

Ethylhexyl Palmitate, Synthetic Wax, Tapioca Starch, Butyloctyl Salicylate, Silica, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Orange Oil Terpenes, Eucalyptus Globulus Leaf Oil, Citrus Limon (Lemon) Peel Oil, Pelargonium Graveolens Flower Oil, Glycine Soja (Soybean) Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Pogostemon Cablin Oil, Ocimum Basilicum (Basil) Oil, Limonene.

Section 51945-4

PLAY

Everyday Sunscreen Stick

Broad Spectrum Sunscreen SPF 50 PA++++

Water and Sweat Resistant (80 minutes)

1.4 oz/40g

Section 55105-1

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

Section 55106-9

Homosalate 7.0%, Octocrylene 7.0%, Octisalate 5.0%, Avobenzone 3.0%

Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs

Dosage and Administration (34068-7)

Apply generously and evenly 15 minutes before sun exposure

Reapply (will vary depending on WR)

after XX minutes of swimming or sweating

Immediately after towel drying

at least every 2 hours

Use a water resistant sunscreen if swimming or sweating

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

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

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.

Section 51727-6 (51727-6)

Ethylhexyl Palmitate, Synthetic Wax, Tapioca Starch, Butyloctyl Salicylate, Silica, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Orange Oil Terpenes, Eucalyptus Globulus Leaf Oil, Citrus Limon (Lemon) Peel Oil, Pelargonium Graveolens Flower Oil, Glycine Soja (Soybean) Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Pogostemon Cablin Oil, Ocimum Basilicum (Basil) Oil, Limonene.

Section 51945-4 (51945-4)

PLAY

Everyday Sunscreen Stick

Broad Spectrum Sunscreen SPF 50 PA++++

Water and Sweat Resistant (80 minutes)

1.4 oz/40g

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

Homosalate 7.0%, Octocrylene 7.0%, Octisalate 5.0%, Avobenzone 3.0%

Advanced Ingredient Data

[{"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "7", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "7", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "BUTYLOCTYL SALICYLATE", "unii": "2EH13UN8D3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SUNFLOWER OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ORANGE TERPENES", "unii": "9J3RG7FX7S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POGOSTEMON CABLIN OIL", "unii": "F3IN55X5PO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYL PALMITATE", "unii": "2865993309", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRUS LIMON (LEMON) PEEL OIL", "unii": "I9GRO824LL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, TAPIOCA", "unii": "24SC3U704I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANIBA ROSAEODORA WOOD", "unii": "NE01NKA8B2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "PARAFFIN", "unii": "I9O0E3H2ZE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SOYBEAN OIL", "unii": "241ATL177A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCIMUM BASILICUM (BASIL) OIL", "unii": "Z129UMU8LE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Stop use and ask a doctor if rash occurs", "34068-7": "Apply generously and evenly 15 minutes before sun exposure Reapply (will vary depending on WR) after XX minutes of swimming or sweating Immediately after towel drying at least every 2 hours Use a water resistant sunscreen if swimming or sweating 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", "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", "50565-1": "Keep out of reach of children. If product is swallowed, get medical help, or contact a poison control center right away.", "51727-6": "Ethylhexyl Palmitate, Synthetic Wax, Tapioca Starch, Butyloctyl Salicylate, Silica, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Orange Oil Terpenes, Eucalyptus Globulus Leaf Oil, Citrus Limon (Lemon) Peel Oil, Pelargonium Graveolens Flower Oil, Glycine Soja (Soybean) Oil, Aniba Rosaeodora (Rosewood) Wood Oil, Pogostemon Cablin Oil, Ocimum Basilicum (Basil) Oil, Limonene.", "51945-4": "PLAY Everyday Sunscreen Stick Broad Spectrum Sunscreen SPF 50 PA++++ Water and Sweat Resistant (80 minutes) 1.4 oz/40g", "55105-1": "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", "55106-9": "Homosalate 7.0%, Octocrylene 7.0%, Octisalate 5.0%, Avobenzone 3.0%"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information