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SPL v2

SPL

SPL Set ID 7cff6270-5c90-49d4-9742-7f4158906b73

Route

TOPICAL

Published

Effective Date 2019-12-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Octinoxate (7.3 g) Oxybenzone (5.8 g) Octisalate (5 g)

Inactive Ingredients

Methyl Salicylate Coconut Oil Yellow Wax Candelilla Wax Lanolin Aloe Vera Whole Shea Butter

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2019-12-11

Description

OCTYL METHOXYCINNAMATE 7.3%, BENZOPHENONE-3 5.8%, OCTYL SALICYLATE 5.0%, HOMOMETHYL SALICYLATE 5.4%

Purpose

SUNSCREEN

Medication Information

Purpose

SUNSCREEN

Description

OCTYL METHOXYCINNAMATE 7.3%, BENZOPHENONE-3 5.8%, OCTYL SALICYLATE 5.0%, HOMOMETHYL SALICYLATE 5.4%

Section 51945-4

Active Ingredients

OCTYL METHOXYCINNAMATE 7.3%, BENZOPHENONE-3 5.8%, OCTYL SALICYLATE 5.0%, HOMOMETHYL SALICYLATE 5.4%

Structured Label Content

Section 51945-4 (51945-4)

Purpose (PURPOSE)

SUNSCREEN

Active Ingredients (ACTIVE INGREDIENTS)

OCTYL METHOXYCINNAMATE 7.3%, BENZOPHENONE-3 5.8%, OCTYL SALICYLATE 5.0%, HOMOMETHYL SALICYLATE 5.4%

Advanced Ingredient Data

[{"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "7.3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OXYBENZONE", "unii": "95OOS7VE0Y", "classCode": "ACTIB", "strengthNumerator": "5.8", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "METHYL SALICYLATE", "unii": "LAV5U5022Y", "classCode": "IACT", "strengthNumerator": "5.4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "COCONUT OIL", "unii": "Q9L0O73W7L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "YELLOW WAX", "unii": "2ZA36H0S2V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CANDELILLA WAX", "unii": "WL0328HX19", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LANOLIN", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA WHOLE", "unii": "KIZ4X2EHYX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SHEA BUTTER", "unii": "K49155WL9Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PURPOSE": "SUNSCREEN", "ACTIVE INGREDIENTS": "OCTYL METHOXYCINNAMATE 7.3%, BENZOPHENONE-3 5.8%, OCTYL SALICYLATE 5.0%, HOMOMETHYL SALICYLATE 5.4%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:59.547461 · Updated: 2026-03-14T22:55:48.069158