DermShield

Manufacturer
USRX LLC
Effective date
2021-10-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:31:56

Label at a glance#

ProductDermShield
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

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

OTC - DO NOT USE SECTION

DO NOT USE - On damaged or broken skin

When using this product

OTC - WHEN USING SECTION

Keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF A RASH OCCURRS

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

WARNINGS SECTION

FOR EXTERNAL USE ONLY

Diretions

DOSAGE & ADMINISTRATION SECTION

  • Apply to all skin exposed to the sun
  • Apply liberally and evenly 15 minutes before sun exposure.
  • Reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours.
  • For children under 6 moths of age: Ask a doctor.

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a BroadSpectrum SPF value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

ISOCETYL STEARATE, SORBITOL, CETEARYL ALCOHOL, CETEARETH-20, TOCOPHERYL ACETATE, ACETYL HEXAPEPTIDE-0, HYDROLYZED RICE PROTEIN, ALCOHOL SDA-40, DIMETHICONE, OCTYL SALICYLATE, CETYL ALCOHOL METHICONE, SODIUM LAURETH SULFATE, CARBOMER, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, FRAGRANCE, TRETHANOLAMINE, STEARIC ACID, LECITHIN, CAPRYLYL GLYCOL, METHYLISOTHIAZOLINONE.

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
70809-190970809-1909-1

Ingredients#

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

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

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
cea65832-405c-1200-e053-2995a90abb4caa07b232-0413-0a6a-e053-2a95a90a04f72021-10-18WarningsExact identifier
spl id: cea65832-405c-1200-e053-2995a90abb4c
spl set id: aa07b232-0413-0a6a-e053-2a95a90a04f7

Reported adverse events (FAERS/openFDA)#

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