f564bbf0-3b5c-4a81-e053-2a95a90a7ea6

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

Active Ingredient

Indications and Usage

Dosage and Administration

Section 50565-1

Section 50570-1

Section 51727-6

Section 51945-4

Section 55105-1


Structured Label Content

Warnings and Precautions (34071-1)

Active Ingredient (55106-9)

Indications and Usage (34067-9)

Dosage and Administration (34068-7)

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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)