ebe024f7-7c45-ad60-e053-2995a90a45d6

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

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)