SPL v2
SPL
SPL Set ID ebe024f7-7c45-ad60-e053-2995a90a45d6
Route
TOPICAL
Published
Effective Date 2022-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (2 g) Phenoxyethanol (1.62 g) Fragrance 13576 (0.98 g) Dehydroacetic Acid (0.14 g) Hydrolyzed Bovine Elastin (base; 1000 Mw) (0.03 g) Octinoxate (0.008 g) Coco-glycerides (5 g) Glycerin (8 g) Hydrolysed Marine Collagen (enzymatic; 2000 Mw) (6.94 g) Cetostearyl Alcohol (0.6 g) Medium-chain Triglycerides (12.58 g) Cetyl Alcohol (12 g) .alpha.-hexylcinnamaldehyde (4 g) Water (0.006 g) Benzoic Acid (0.024 g) Centaurea Cyanus Flower (0.16 g) Viola Odorata (140 mL) Limonene, (+)- (1.4 g) Potassium Phosphate, Unspecified Form (0.24 g) .beta.-citronellol, (r)- (0.1 g) Isomethyl-.alpha.-ionone (0.05 g) Butylated Hydroxytoluene (0.038 g)
Inactive Ingredients
Citric Acid Monohydrate Sodium Benzoate Potassium Sorbate Sodium Cetostearyl Sulfate Edetate Disodium Anhydrous Sodium Hydroxide Sodium Phosphate, Dibasic, Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-10-25 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)