MEDERMA SCAR CREAM- avobenzone, octocrylene, and oxybenzone cream

Mederma Scar Cream by

Drug Labeling and Warnings

Mederma Scar Cream by is a Otc medication manufactured, distributed, or labeled by HRA Pharma America, Inc., Merz Pharma GmbH & Co KGaA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Octocrylene 10%

Oxybenzone 6%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

Warnings

• Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
• For external use only

Do not use on

• Damaged or broken skin

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

When using this product

• Keep out of eyes
• Rinse with water to remove

Stop use and ask a doctor

• If rash occurs

Directions

• For sunscreen use: Apply liberally 15 minutes before sun exposure
• Reapply at least every 2 hours
• Children under 6 months: Ask a doctor
• Use a water-resistant sunscreen if swimming or sweating

Other Information

• Store at room temperature
• Protect this product from excessive heat and direct sun

Inactive Ingredients

• Water, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Alcohol, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Panthenol, Glycerin, Pentylene Glycol, Phenoxyethanol, Butyrospermum Parkii (Shea) Butter, Allium Cepa (Onion) Bulb Extract, Ammonium Acryloyldimethyltaurate/VP Copolymer, Fragrance, Squalane, Methylparaben, Xanthan Gum, Propylparaben, Disodium EDTA, Sodium Hyaluronate, Ethylparaben, Ceramide NP, Tocopherol.

Questions or Comments

• For more information call 1-833-426-6733 or visit www.mederma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MEDERMA®

Scar Cream + SPF 30  

Clinically shown to visibly reduce the appearance of scars while protecting from sun damage

No. 1 Doctor & Pharmacist recommended scar brand

Sunscreen

1 x CREAM TUBE

NET WT. 0.7 0z (20g)

Unique Triple-Action Formula penetrates into the skin

INGREDIENTS AND APPEARANCE

MEDERMA SCAR CREAM 
avobenzone, octocrylene, and oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73302-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ALCOHOL (UNII: 3K9958V90M)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
PANTHENOL (UNII: WV9CM0O67Z)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SHEA BUTTER (UNII: K49155WL9Y)
ONION (UNII: 492225Q21H)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
SQUALANE (UNII: GW89575KF9)
METHYLPARABEN (UNII: A2I8C7HI9T)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ETHYLPARABEN (UNII: 14255EXE39)
CERAMIDE NP (UNII: 4370DF050B)
Tocopherol (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73302-205-20	1 in 1 CARTON	08/20/2021
1		20 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/20/2021

Labeler - HRA PHARMA AMERICA, INC. (081160441)