SPL v2
SPL
SPL Set ID ec83846f-11c0-8f59-e053-2995a90ab9d2
Route
TOPICAL
Published
Effective Date 2022-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (3.5982 g) Titanium Dioxide (0.425 g) Chlorphenesin (0.1 g) Octisalate (1.8 g) Butylene Glycol (2.5 g) Propylene Glycol (2.1 g) Poly(methyl Methacrylate; 450000 Mw) (0.00025 g) Water (27.55 mL) Silicon Dioxide (0.575 g) Butylated Hydroxytoluene (0.4125 g) Dimethicone (0.025 g) Carbomer Homopolymer, Unspecified Type (0.0018 g) C20-22 Alcohols (1.25 g) Fragrance 13576 (0.15 g) Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) (0.3375 g) Tromethamine (0.3 g) Bemotrizinol (0.075 g) Polyethylene Glycol 400 (0.22 g) Ascorbyl Palmitate (1.45 g) Phenoxyethanol (0.14225 g) Octocrylene (0.00125 g) Avobenzone (0.35 g) Linolenic Acid (0.00275 g) Ascorbic Acid (0.006 g) Tocopherol (0.49725 g) Linoleic Acid (0.005 g) Glycerin
Inactive Ingredients
Citric Acid Monohydrate C20-22 Alkyl Phosphate Edetate Disodium Anhydrous Potassium Cetyl Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-11-02 Until 2028-03-09


Medication Information

Warnings and Precautions

Indications and Usage

Dosage and Administration

Section 50565-1

Section 50570-1

Section 51727-6

Section 51945-4

Section 55105-1

Section 55106-9


Structured Label Content

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

Warnings and Precautions (34071-1)

Section 50565-1 (50565-1)

Section 50570-1 (50570-1)

Section 51727-6 (51727-6)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)