SPL v2
SPL
SPL Set ID eb68c3ab-7835-1a1c-e053-2995a90a0d66
Route
TOPICAL
Published
Effective Date 2022-10-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (0.08784 g) Geraniol (0.003398 g) Isopropyl Alcohol (0.002132 g) Alcohol (0.002 g) Oxybenzone (3.5436 mL) Phenoxyethanol (1.6 g) Tea Tree Oil (1.3 g) Imidurea (0.585 g) Water (0.1 g) Glyceryl Stearate Se (0.4 g) Carbomer Homopolymer, Unspecified Type (155.839258 mL) Tioxolone (6 g) Linalool, (+/-)- (0.8 g) Fd&c Yellow No. 5 (0.3 g) Benzyl Benzoate (0.026404 g) Panthenol (0.01044 g) Coumarin (0.004 g) C12-20 Acid Peg-8 Ester (0.04 g) Arctium Lappa Root (0.000892 g) Propylparaben (0.003924 g) Cetyl Alcohol (0.00156 g) Yeast, Unspecified (0.03 g) Riboflavin (4 g) Propylene Glycol (0.012 g) Cetearyl Ethylhexanoate (0.003512 g) Hydroxyethyl Cellulose, Unspecified (0.28 g) Butylated Hydroxytoluene (0.015 g) Citral (0.2 g) Green Tea Leaf (0.00012 g) Allantoin (6.469044 g) Limonene, (+)- (0.8 mL) Niacinamide (10 g) Powdered Cellulose (0.12863 g) Polyoxyl 40 Hydrogenated Castor Oil (0.104 g) .alpha.-hexylcinnamaldehyde (0.01032 g) Octinoxate (0.00679 g) Methylparaben (0.061818 g) Fragrance 13576 (0.02 g)
Inactive Ingredients
Pyridoxine Hydrochloride Cetyl Phosphate Sodium Benzoate Sodium Chloride Citric Acid Monohydrate Thiamine Hydrochloride Edetate Disodium Anhydrous Trolamine Potassium Sorbate Sodium Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-10-19 Until 2027-02-20


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)