FDA.reportPublic FDA data

DermaShield

Manufacturer
USRX LLC
Effective date
2019-09-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:09:46

Label at a glance#

ProductDermaShield
Active ingredientOCTINOXATE, TITANIUM DIOXIDE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DermashieldDermashield

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT:

  • TITANIUM DIOXIDE 2%
  • OCTINOXATE 7%

OTC - PURPOSE SECTION

Sunscreen

INDICATIONS & USAGE SECTION

WARNINGS SECTION

FOR EXTERNAL USE ONLY

OTC - DO NOT USE SECTION

DO NOT USE - On damaged or broken skin

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF A RASH OCCURRS

DOSAGE & ADMINISTRATION SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70809-190170809-1901-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
ALUMINUM OXIDELMI26O6933IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
CAPRYLYL GLYCOL00YIU5438UIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
SORBITOL506T60A25RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ISOCETYL STEARATE3RJ7186O9WIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
METHICONE (20 CST)6777U11MKTIACT
CETYL ALCOHOL936JST6JCNIACT
OCTISALATE4X49Y0596WIACT
DIMETHICONE92RU3N3Y1OIACT
ACETYL HEXAPEPTIDE-8L4EL31FWILIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

Source Document#

Source XML · Source PDF

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
aa6b08a5-f50d-5781-e053-2a95a90aa4388d33f570-9426-3299-e053-2995a90aab5a2020-07-14WarningsExact identifier
spl set id: 8d33f570-9426-3299-e053-2995a90aab5a

Reported adverse events (FAERS/openFDA)#

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