FDA.reportPublic FDA data

Scar Cream SPF 30 - Genomma Lab | Derma Care Research Labs

Manufacturer
Genomma Lab | Derma Care Research Labs
Effective date
2019-02-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:02:07

Label at a glance#

ProductScar Cream SPF 30
Active ingredientAVOBENZONE, OXYBENZONE, OCTOCRYLENE
Label structure8 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply generously and evenly 15 minutes before sun exposure. Reapply: at least every 2 hours use a water resistant sunscreen if swimming or sweating Children under 6 months: ask a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

DOSAGE & ADMINISTRATION SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only.

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 and early skin aging.

Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse eyes with water to remove.

Stop use and ask a doctor if rash occurs.

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.

Directions

INDICATIONS & USAGE SECTION

Apply generously and evenly 15 minutes before sun exposure. Reapply:

  • at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating

Children under 6 months: ask a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Allium Cepa (Onion) Bulb Extract, Sorbitan Isostearate, Sorbitol, Polyester-7, VP/Eicosene Copolymer, Glyceryl Caprylate, decolorized Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Lepidium Sativum (Cress) Sprout Extract, Allantoin, Tocopherol, Stearic Acid, Polysorbate 80, Carbomer, Dimethicone, Disodium EDTA, Lecithin, Glycerin, Neopentyl Glycol Diheptanoate, Polyglyceryl-3 Distearate, Benzyl Alcohol, Triethanolamine, Phenoxyethanol

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-119-01Scar Cream SPF 3019.8 g in 1 TUBECREAM19.81
50066-119-01Scar Cream SPF 301 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-119SCAR CREAM SPF 30 (AVOBENZONE, OCTOCRYLENE, OXYBENZONE) CREAM [GENOMMA LAB]1Current NDC, Legacy NDC, 2 package rows20190223_827d4e72-4bb7-2ec7-e053-2991aa0a983e.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-11950066-119-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
GARDEN CRESS SPROUTPWQ18YNR62IACT
GLYCERINPDC6A3C0OXIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
POLYGLYCERYL-3 DISTEARATEZI1LK470XVIACT
POLYSORBATE 806OZP39ZG8HIACT
TROLAMINE9O3K93S3TKIACT
JOJOBA OIL724GKU717MIACT
BENZYL ALCOHOLLKG8494WBHIACT
AVOBENZONEG63QQF2NOXACTIB
OXYBENZONE95OOS7VE0YACTIB
OCTOCRYLENE5A68WGF6WMACTIB
EDETATE DISODIUM7FLD91C86KIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
MATRICARIA RECUTITA LEAF6I9LN466F0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
DIMETHICONE 200RGS4T2AS00IACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
VINYLPYRROLIDONE/EICOSENE COPOLYMER035MV9S1C3IACT
WATER059QF0KO0RIACT
ONION492225Q21HIACT
SORBITOL506T60A25RIACT
POLYESTER-70841698D2FIACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ALLANTOIN344S277G0ZIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT

Source Document#

Source XML

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
Scar Cream SPF 30AVOBENZONE, OCTOCRYLENE, OXYBENZONEGenomma Lab827d4e72-4bb7-2ec7-e053-2991aa0a983e2019-02-22WarningsExact identifier
ndc (package): 50066-119-01
ndc (product): 50066-119
ndc11 (package): 50066011901
spl id: 827d7500-26c6-3110-e053-2991aa0a31dd
spl set id: 827d4e72-4bb7-2ec7-e053-2991aa0a983e

Reported adverse events (FAERS/openFDA)#

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