85594-004-01 Facial Moisturizing Sunscreen

SPL v1

SPL

SPL Set ID 34e8091e-d06d-4142-e063-6294a90a1d40

Route

CUTANEOUS

Published

Effective Date 2025-05-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Titanium Dioxide (5 mg)

Inactive Ingredients

Hydrolyzed Porcine Collagen (enzymatic; 3000 Mw) Tocopherol Glycerin .alpha.-tocopherol, Dl- Aqua

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-05-12

Description

Titanium Dioxide

Medication Information

Warnings and Precautions

Sensitivity testing for new users. Apply product sparingly to one or twosmall affected areas forthe first 3 days. lf no discomfort occurs. Please follow the instructions above.

Indications and Usage

As the final step inyour skin care routine, use before makeup. lt is highly recommended to apply sunscreen at least30 minutes before starting outdoor activities for maximum effectiveness.

Dosage and Administration

Apply an adequate amount (about a coin-sized portion or 2mg/cm²) evenly to the face and neck.

Description

Titanium Dioxide

Section 50565-1

KEEP THE PRODUCT OUT OF REACH OF CHILDREN to

Section 50566-9

his product may cause allergic reactions in asmall number of people.

lf you experience any discomfort,please stop using it immediately.

Section 50570-1

Not suitable for use by children, pregnantor breast feeding people.

Section 51727-6

Aqua，Glycerin，Hydrolyzed Collagen，Tocopherol，DL-Alpha

Section 51945-4

Section 55105-1

Apply an adequate amount (about a coin-sized portion or 2mg/cm²) evenly to the face and neck.

Section 55106-9

Titanium Dioxide

Structured Label Content

Indications and Usage (34067-9)

As the final step inyour skin care routine, use before makeup. lt is highly recommended to apply sunscreen at least30 minutes before starting outdoor activities for maximum effectiveness.

Dosage and Administration (34068-7)

Apply an adequate amount (about a coin-sized portion or 2mg/cm²) evenly to the face and neck.

Warnings and Precautions (34071-1)

Sensitivity testing for new users. Apply product sparingly to one or twosmall affected areas forthe first 3 days. lf no discomfort occurs. Please follow the instructions above.

Section 50565-1 (50565-1)

KEEP THE PRODUCT OUT OF REACH OF CHILDREN to

Section 50566-9 (50566-9)

his product may cause allergic reactions in asmall number of people.

lf you experience any discomfort,please stop using it immediately.

Section 50570-1 (50570-1)

Not suitable for use by children, pregnantor breast feeding people.

Section 51727-6 (51727-6)

Aqua，Glycerin，Hydrolyzed Collagen，Tocopherol，DL-Alpha

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Apply an adequate amount (about a coin-sized portion or 2mg/cm²) evenly to the face and neck.

Section 55106-9 (55106-9)

Titanium Dioxide

Advanced Ingredient Data

[{"name": "HYDROLYZED PORCINE COLLAGEN (ENZYMATIC; 3000 MW)", "unii": "0K9R94573C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL, DL-", "unii": "7QWA1RIO01", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "AQUA", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "As the final step inyour skin care routine, use before makeup. lt is highly recommended to apply sunscreen at least30 minutes before starting outdoor activities for maximum effectiveness.", "34068-7": "Apply an adequate amount (about a coin-sized portion or 2mg/cm²) evenly to the face and neck.", "34071-1": "Sensitivity testing for new users. Apply product sparingly to one or twosmall affected areas forthe first 3 days. lf no discomfort occurs. Please follow the instructions above.", "50565-1": "KEEP THE PRODUCT OUT OF REACH OF CHILDREN to", "50566-9": "his product may cause allergic reactions in asmall number of people. lf you experience any discomfort,please stop using it immediately.", "50570-1": "Not suitable for use by children, pregnantor breast feeding people.", "51727-6": "Aqua，Glycerin，Hydrolyzed Collagen，Tocopherol，DL-Alpha", "55105-1": "Apply an adequate amount (about a coin-sized portion or 2mg/cm²) evenly to the face and neck.", "55106-9": "Titanium Dioxide"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:06.533643 · Updated: 2026-03-14T23:08:42.212838