24c1c4dd-29df-f626-e063-6294a90ad3e0

SPL v3

SPL

SPL Set ID 24c1c4dd-29df-f626-e063-6294a90ad3e0

Route

topical

Published

Effective Date 2020-02-17

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

octisalate (0.21 g) avobenzone (0.09 g) octocrylene (0.06 g) octinoxate (0.28 g)

Inactive Ingredients

soybean oil sunflower oil mono/diglycerides canola oil sunflower oil tocopherol rosemary white wax olive oil cannabis sativa seed oil aloe vera leaf

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-10-18

Description

Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%

Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Indications and Usage

Helps prevent sunburn

Dosage and Administration

Apply liberally 15 minutes before sun exposure

Description

Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Rash Occurs

Section 50567-7

Keep out of eyes. Rinse well with water to remove.

Section 50570-1

on damaged or broken skin.

Section 51727-6

Sunflower Oil*, Beeswax, Olive Oil*, Flavor, Soybean Oil, Rosemary Extract, Sunflower Seed Oil Glycerides, Tocopherol, Hemp Seed Oil*, Aloe Extract, Canola Oil. * Organic

Section 51945-4

Section 55105-1

Sunscreen

Section 60562-6

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months of age: Ask a doctor

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Avobenzone 2.0%

Octinoxate 6.5%

Octisalate 5.0%

Octocrylene 1.5%

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

Apply liberally 15 minutes before sun exposure

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 50566-9 (50566-9)

Rash Occurs

Section 50567-7 (50567-7)

Keep out of eyes. Rinse well with water to remove.

Section 50570-1 (50570-1)

on damaged or broken skin.

Section 51727-6 (51727-6)

Sunflower Oil*, Beeswax, Olive Oil*, Flavor, Soybean Oil, Rosemary Extract, Sunflower Seed Oil Glycerides, Tocopherol, Hemp Seed Oil*, Aloe Extract, Canola Oil. * Organic

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 60562-6 (60562-6)

Apply liberally 15 minutes before sun exposure

Use a water resistant sunscreen if swimming or sweating

Reapply at least every 2 hours

Children under 6 months of age: Ask a doctor

Advanced Ingredient Data

[{"name": "SOYBEAN OIL", "unii": "241ATL177A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUNFLOWER OIL MONO/DIGLYCERIDES", "unii": "HS7EB0C1ZH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CANOLA OIL", "unii": "331KBJ17RK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUNFLOWER OIL", "unii": "3W1JG795YI", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ROSEMARY", "unii": "IJ67X351P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WHITE WAX", "unii": "7G1J5DA97F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OLIVE OIL", "unii": "6UYK2W1W1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CANNABIS SATIVA SEED OIL", "unii": "69VJ1LPN1S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "0.21", "strengthDenominator": "4.25", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "0.09", "strengthDenominator": "4.25", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTOCRYLENE", "unii": "5A68WGF6WM", "classCode": "ACTIB", "strengthNumerator": "0.06", "strengthDenominator": "4.25", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "0.28", "strengthDenominator": "4.25", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Helps prevent sunburn", "34068-7": "Apply liberally 15 minutes before sun exposure", "34071-1": "For external use only", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Rash Occurs", "50567-7": "Keep out of eyes. Rinse well with water to remove.", "50570-1": "on damaged or broken skin.", "51727-6": "Sunflower Oil*, Beeswax, Olive Oil*, Flavor, Soybean Oil, Rosemary Extract, Sunflower Seed Oil Glycerides, Tocopherol, Hemp Seed Oil*, Aloe Extract, Canola Oil. * Organic", "55105-1": "Sunscreen", "55106-9": "Avobenzone 2.0% Octinoxate 6.5% Octisalate 5.0% Octocrylene 1.5%", "60562-6": "Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months of age: Ask a doctor"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:54.018270 · Updated: 2026-03-06T01:20:24.230744