Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID d089ce4c-5df6-4add-bb67-4ea8385d20b4

Route

TOPICAL

Published

Effective Date 2010-10-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Octinoxate (6 mL) Titanium Dioxide (3.4 mL) Ensulizole (2 mL) Avobenzone (0.8 mL)

Inactive Ingredients

Cyclomethicone Propylene Glycol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2010-10-07

Description

OCTINOXATE 6%, TITANIUM DIOXIDE 3.4%, ENSULIZOLE 2%, AVOBENZONE 0.8%

Medication Information

Dosage and Administration

Apply evenly before sun exposure and as needed.

Description

OCTINOXATE 6%, TITANIUM DIOXIDE 3.4%, ENSULIZOLE 2%, AVOBENZONE 0.8%

Section 50566-9

Rash or irritation develops and lasts.

Section 50567-7

Keep out of eyes. Rinse with water to remove.

Section 51727-6

CYCLOMETHICONE, PROPYLENE GLYCOL.

Section 51945-4

Myung Han Miindo

Make Up Base

Section 55105-1

Provides high protection against sunburn and tanning.

Section 55106-9

OCTINOXATE 6%, TITANIUM DIOXIDE 3.4%, ENSULIZOLE 2%, AVOBENZONE 0.8%

Structured Label Content

Dosage and Administration (34068-7)

Apply evenly before sun exposure and as needed.

Section 50566-9 (50566-9)

Rash or irritation develops and lasts.

Section 50567-7 (50567-7)

Keep out of eyes. Rinse with water to remove.

Section 51727-6 (51727-6)

CYCLOMETHICONE, PROPYLENE GLYCOL.

Section 51945-4 (51945-4)

Myung Han Miindo

Make Up Base

Section 55105-1 (55105-1)

Provides high protection against sunburn and tanning.

Section 55106-9 (55106-9)

OCTINOXATE 6%, TITANIUM DIOXIDE 3.4%, ENSULIZOLE 2%, AVOBENZONE 0.8%

Advanced Ingredient Data

[{"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "3.4", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ENSULIZOLE", "unii": "9YQ9DI1W42", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "AVOBENZONE", "unii": "G63QQF2NOX", "classCode": "ACTIB", "strengthNumerator": "0.8", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "CYCLOMETHICONE", "unii": "NMQ347994Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34068-7": "Apply evenly before sun exposure and as needed.", "50566-9": "Rash or irritation develops and lasts.", "50567-7": "Keep out of eyes. Rinse with water to remove.", "51727-6": "CYCLOMETHICONE, PROPYLENE GLYCOL.", "51945-4": "Myung Han Miindo Make Up Base", "55105-1": "Provides high protection against sunburn and tanning.", "55106-9": "OCTINOXATE 6%, TITANIUM DIOXIDE 3.4%, ENSULIZOLE 2%, AVOBENZONE 0.8%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:08.690966 · Updated: 2026-03-14T22:52:29.225907