SPL v2
SPL
SPL Set ID f564bbf0-3b5c-4a81-e053-2a95a90a7ea6
Route
TOPICAL
Published
Effective Date 2023-02-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenoxyethanol (1.8 g) Fragrance 13576 (0.8 g) Ethylhexylglycerin (0.4 g) Avobenzone (0.2 g) .beta.-sitosterol (2 g) Hydrolysed Marine Collagen (enzymatic; 2000 Mw) (0.01 g) Linoleic Acid (0.16 g) Tocopherol (0.08 g) Malva Sylvestris Flowering Top (0.06 g) Papaver Rhoeas Flower (0.04 g) Medium-chain Triglycerides (34 g) Shea Butter (4 g) Linolenic Acid (3 g) Polyglyceryl-4 Isostearate (2.7 g) Hexyl Laurate (1 g) White Wax (125.88 g) Hydrogenated Castor Oil (7 g) Amiloxate (1.6 g) Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) (0.00004 g) Squalane Water Glycerin Cetearyl Ethylhexanoate
Inactive Ingredients
Edetate Disodium Anhydrous Magnesium Sulfate, Unspecified Potassium Sorbate Sodium Benzoate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2023-02-23 Until 2026-10-20


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)