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SPL v1

SPL

SPL Set ID 286182a5-f383-4b14-9ddd-0a63942e371e

Route

TOPICAL

Published

Effective Date 2009-11-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Titanium (3 mL) Octinoxate (1.8 mL) Zinc (0.3 mL)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2009-11-01

Description

ACTIVE INGREDIENTS: Titanium Dioxide, Ethylhexyl Methoxycinnamate, Zinc Oxide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Portulaca Oleracea Extract, Citrus Grandis (Grapefruit) Peel Extract, Camellia Sinensis Leaf Extract

Medication Information

Description

Section 50565-1

CAUTION: Keep away from children.

Section 50567-7

DIRECTION OF USE:

Apply thin layer of blemish balm onto all over the face. Use fingertips to spread gently until it has been completely absorbed.

Section 51945-4

Label18c

Section 55106-9

ACTIVE INGREDIENTS:

Titanium Dioxide, Ethylhexyl Methoxycinnamate, Zinc Oxide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Portulaca Oleracea Extract, Citrus Grandis (Grapefruit) Peel Extract, Camellia Sinensis Leaf Extract

Structured Label Content

Section 50565-1 (50565-1)

CAUTION: Keep away from children.

Section 50567-7 (50567-7)

DIRECTION OF USE:

Apply thin layer of blemish balm onto all over the face. Use fingertips to spread gently until it has been completely absorbed.

Section 51945-4 (51945-4)

Label18c

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS:

Advanced Ingredient Data

[{"name": "TITANIUM", "unii": "D1JT611TNE", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "60", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "1.8", "strengthDenominator": "60", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "ZINC", "unii": "J41CSQ7QDS", "classCode": "ACTIB", "strengthNumerator": "0.3", "strengthDenominator": "60", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"50565-1": "CAUTION: Keep away from children.", "50567-7": "DIRECTION OF USE: Apply thin layer of blemish balm onto all over the face. Use fingertips to spread gently until it has been completely absorbed.", "51945-4": "Label18c", "55106-9": "ACTIVE INGREDIENTS: Titanium Dioxide, Ethylhexyl Methoxycinnamate, Zinc Oxide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Portulaca Oleracea Extract, Citrus Grandis (Grapefruit) Peel Extract, Camellia Sinensis Leaf Extract"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:54:58.348124 · Updated: 2026-03-14T22:52:13.708968