DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Ethylhexyl Salicylate (5 g) Butyl Methoxydibenzoylmethane (3 g) Octocrylene (7 g) Homosalate (15 g)

Inactive Ingredients

Ppg-5-ceteth-20 Alcohol Fragrance 13576 C12-15 Alkyl Benzoate Tocopherol Aloe Vera Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-12-02

Medication Information

Warnings and Precautions

WarningsFlammable. Do nat use near heat, flame, or whilesmoking. Contents under pressure. Do not puncture orincinerate, Do not store at temperature above 120 °F

For external use only.

Indications and Usage

Sun Protection Measures: Spendingtime in the sun increases your risk of skin cancer andearly skin aging. To decrease this risk, regularly use asunscreen with a broad spectrum spf value of 15 orhigher and other sun protection measure including:limit time in the sun, especially from 10a.m. to 2p.m.Wear long-sleeved shirts, pants, hats, and sunglasses

Dosage and Administration

Apply liberally 15 minutes before sunexposure, Reapply: After 80 minutes of swimmingor sweating." immediately after towel dryingAt least every 2 hours. Children under 6 months.Ask a doctor

Description

Homosalate Octocrylene Ethylhexyl Salicylate (Octisalate) Butyl Methoxydibenzoylmethane (Avobenzone)

Section 50565-1

Keep out of reach of children. if product isswallowed, get medical help or contact a PoisonControl Centre right away

Section 51727-6

Inactive Ingredients: Alcohol Denat. C12-15Alkyl Benzoate, Acrylates/ 0ctacrylamide Copolymer,PPG-5-Ceteth-20, Aloe Barbadensis Leaf ExtractFragrance, Tocopherol.

Section 51945-4

Section 55105-1

Helps prevent sunburn. lf used as directedwith other sun protection measures (see Directions).decreases the risk of skin cancer and early agingcaused by the sun.

Section 55106-9

Homosalate

Octocrylene

Ethylhexyl Salicylate

(Octisalate)

Butyl Methoxydibenzoylmethane

(Avobenzone)

Structured Label Content

Indications and Usage (34067-9)

Sun Protection Measures: Spendingtime in the sun increases your risk of skin cancer andearly skin aging. To decrease this risk, regularly use asunscreen with a broad spectrum spf value of 15 orhigher and other sun protection measure including:limit time in the sun, especially from 10a.m. to 2p.m.Wear long-sleeved shirts, pants, hats, and sunglasses

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sunexposure, Reapply: After 80 minutes of swimmingor sweating." immediately after towel dryingAt least every 2 hours. Children under 6 months.Ask a doctor

Warnings and Precautions (34071-1)

WarningsFlammable. Do nat use near heat, flame, or whilesmoking. Contents under pressure. Do not puncture orincinerate, Do not store at temperature above 120 °F

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. if product isswallowed, get medical help or contact a PoisonControl Centre right away

Section 51727-6 (51727-6)

Inactive Ingredients: Alcohol Denat. C12-15Alkyl Benzoate, Acrylates/ 0ctacrylamide Copolymer,PPG-5-Ceteth-20, Aloe Barbadensis Leaf ExtractFragrance, Tocopherol.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps prevent sunburn. lf used as directedwith other sun protection measures (see Directions).decreases the risk of skin cancer and early agingcaused by the sun.

Section 55106-9 (55106-9)

Homosalate

Octocrylene

Ethylhexyl Salicylate

(Octisalate)

Butyl Methoxydibenzoylmethane

(Avobenzone)

Advanced Ingredient Data

[{"name": "PPG-5-CETETH-20", "unii": "4AAN25P8P4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYL SALICYLATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYL METHOXYDIBENZOYLMETHANE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "C12-15 ALKYL BENZOATE", "unii": "A9EJ3J61HQ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "7", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HOMOSALATE", "unii": "V06SV4M95S", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Sun Protection Measures: Spendingtime in the sun increases your risk of skin cancer andearly skin aging. To decrease this risk, regularly use asunscreen with a broad spectrum spf value of 15 orhigher and other sun protection measure including:limit time in the sun, especially from 10a.m. to 2p.m.Wear long-sleeved shirts, pants, hats, and sunglasses", "34068-7": "Apply liberally 15 minutes before sunexposure, Reapply: After 80 minutes of swimmingor sweating." immediately after towel dryingAt least every 2 hours. Children under 6 months.Ask a doctor", "34071-1": "WarningsFlammable. Do nat use near heat, flame, or whilesmoking. Contents under pressure. Do not puncture orincinerate, Do not store at temperature above 120 °F For external use only.", "50565-1": "Keep out of reach of children. if product isswallowed, get medical help or contact a PoisonControl Centre right away", "51727-6": "Inactive Ingredients: Alcohol Denat. C12-15Alkyl Benzoate, Acrylates/ 0ctacrylamide Copolymer,PPG-5-Ceteth-20, Aloe Barbadensis Leaf ExtractFragrance, Tocopherol.", "55105-1": "Helps prevent sunburn. lf used as directedwith other sun protection measures (see Directions).decreases the risk of skin cancer and early agingcaused by the sun.", "55106-9": "Homosalate Octocrylene Ethylhexyl Salicylate (Octisalate) Butyl Methoxydibenzoylmethane (Avobenzone)"}