SPL v2
SPL
SPL Set ID e99d92c4-8768-9c0a-e053-2a95a90a609e
Route
TOPICAL
Published
Effective Date 2022-10-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-10-15 Until 2027-04-29


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)