SPL v2
SPL
SPL Set ID 34080e9c-1637-cf25-e063-6394a90ace76
Route
TOPICAL
Published
Effective Date 2025-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (5 g) Octisalate (4 g) Zinc Oxide
Inactive Ingredients
Water Citrus Aurantium Amara (bitter Orange) Peel Oil Cupressus Sempervirens Leaf Oil Sorbitan Stearate Watermelon Cinnamomum Camphora (camphor) Leaf Oil Caprylic/capric Triglyceride Adenosine Citrus Aurantium Dulcis (orange) Peel Oil Citrus Limon (lemon) Peel Oil Xanthan Gum Citric Acid Squalane Helianthus Annuus Sprout Rosa Canina Fruit Oil Citrus Aurantium Amara (bitter Orange) Flower Oil Lavandula Hybrida Oil Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Isohexadecane Polysorbate 60 Phenoxyethanol Glyceryl Stearate Se Resveratrol Caesalpinia Spinosa Fruit Pod Punica Granatum Fruit Juice Maltodextrin Ricinus Communis (castor) Seed Oil Sorbitan Isostearate Sodium Hyaluronate Niacinamide Ethylhexylglycerin Myrocarpus Frondosus Whole .alpha.-tocopherol Acetate Glycerin Aloe Barbadensis Leaf Juice Daucus Carota Sativa (carrot) Seed Oil Polysorbate 20 Butyloctyl Salicylate Camellia Oleifera Leaf Dodecane Helianthus Annuus (sunflower) Seed Oil Limnanthes Alba (meadowfoam) Seed Oil Cymbopogon Citratus Leaf Oil Jasminum Officinale (jasmine) Flower

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01


Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 51727-6

Section 51945-4

Section 55105-1


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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)