SPL v1
SPL
SPL Set ID 3cbd0550-b6e5-3e86-e063-6394a90ac07f
Route
TOPICAL
Published
Effective Date 2025-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (7.5 g) Avobenzone (3 g) Octisalate (4.5 g)
Inactive Ingredients
Menthol Punica Granatum Sterols Cocos Nucifera (coconut) Fruit Beeswax Helianthus Annuus (sunflower) Seed Oil Oryza Sativa (rice) Germ Powder Silica Sucralose Polysorbate 80 Melaleuca Alternifolia (tea Tree) Leaf Oil Acacia Senegal Gum Simmondsia Chinensis (jojoba) Seed Oil .alpha.-tocopherol Acetate, Dl- Niacin Zea Mays (corn) Starch Cetyl Alcohol Theobroma Cacao (cocoa) Seed Butter Aleurites Moluccana Seed Euphorbia Cerifera (candelilla) Wax Riboflavin Camphor (natural) Butyrospermum Parkii (shea) Butter Mentha Piperita (peppermint) Oil Vitis Vinifera (grape) Seed Oil Biotin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-19


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)