FDA.reportPublic FDA data

MEDERMA®

Manufacturer
PMI Branded Pharmaceuticals, Inc.
Effective date
2026-07-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-07-21 05:10:19

Label at a glance#

ProductMederma Scar Cream
Active ingredientAVOBENZONE, OCTOCRYLENE, OXYBENZONE
Label structure9 sections

Indications and uses

• Helps prevent sunburn

Dosage and administration

• 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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Octocrylene 10%

Oxybenzone 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

  • 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

OTC - DO NOT USE SECTION

  • Damaged or broken skin

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

When using this product

OTC - WHEN USING SECTION

  • Keep out of eyes
  • Rinse with water to remove

Stop use and ask a doctor

OTC - STOP USE SECTION

  • If rash occurs

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

  • 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

OTC - QUESTIONS SECTION

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

carton
carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73302-20573302-205-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
Water059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
ALCOHOL3K9958V90MIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
PANTHENOLWV9CM0O67ZIACT
GLYCERINPDC6A3C0OXIACT
PENTYLENE GLYCOL50C1307PZGIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SHEA BUTTERK49155WL9YIACT
ONION492225Q21HIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
SQUALANEGW89575KF9IACT
METHYLPARABENA2I8C7HI9TIACT
XANTHAN GUMTTV12P4NEEIACT
PROPYLPARABENZ8IX2SC1OHIACT
Edetate Disodium Anhydrous8NLQ36F6MMIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ETHYLPARABEN14255EXE39IACT
CERAMIDE NP4370DF050BIACT
TocopherolR0ZB2556P8IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-01-27full-release2026-06-01 00:53:47

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mederma Scar CreamAVOBENZONE, OCTOCRYLENE, AND OXYBENZONEPMI Branded Pharmaceuticals, Inc.f9be5adb-dce3-4b17-939f-d80d486f2cb02026-07-16WarningsExact identifier
ndc (package): 73302-205-20
ndc (product): 73302-205
ndc11 (package): 73302020520
spl id: 8f86b162-f9aa-4806-a31d-da3573416c2d
spl set id: f9be5adb-dce3-4b17-939f-d80d486f2cb0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.