SPL v1
SPL
SPL Set ID 41367f05-59d8-6736-e063-6394a90a5f17
Route
TOPICAL
Published
Effective Date 2025-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4 g) Zinc Oxide (15.5 g)
Inactive Ingredients
Lauryl Methicone Aleurites Moluccana Seed Sodium Chloride Ferric Oxide Red Phenoxyethanol Propanediol .alpha.-tocopherol Acetate Limnanthes Alba (meadowfoam) Seed Oil Ethylhexyl Palmitate Tetrahexyldecyl Ascorbate Allantoin Water Camellia Sinensis Leaf Dimethicone Matricaria Chamomilla Flowering Top Ethylhexylglycerin Aloe Barbadensis Leaf Citrus Grandis (grapefruit) Peel Oil Argania Spinosa Kernel Oil Cucumis Sativus Leaf Helianthus Annuus (sunflower) Seed Oil Sodium Hyaluronate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-15


Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1

Section 55106-9

Section 60561-8


Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 50565-1 (50565-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)

Section 60561-8 (60561-8)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)