FDA.reportPublic FDA data

Derma E Sun Defense

Manufacturer
derma e | Topiderm, Inc.
Effective date
2024-07-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:11

Label at a glance#

ProductDerma E Sun Defense SPF 30
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

apply liberally 15 minutes before sun exposure Children under 6 months 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 this risk, regularly use a sunscreen with broad spectrum SPF 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-sleeve shirts, pant...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientPurpose
Zinc Oxide 19.5% }Sunscreen
Titanium Dioxide 2.64% }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

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • Children under 6 months 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 this risk, regularly use a sunscreen with broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aluminum Oxide, Ascorbic Acid, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Caprylyl Caprylate/Caprate, Cellulose Gum, Cetearyl Alcohol, Cetearyl Glucoside, Cetearyl Olivate, Coco-Caprylate, Coco-Glucoside, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Isostearic Acid, Lecithin, Microcrystalline Cellulose, Panthenol, Phenoxyethanol, Phytic Acid, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Purified Water, Sclerotium Gum, Butyrospermum Parkii (Shea) Butter, Sodium Phytate, Sorbitan Olivate, Stearic Acid, Stearyl/Octyldodecyl Citrate Crosspolymer, Tocopheryl Acetate, Xanthan Gum.

*Certified Organic Ingredients

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-933-9344 or visit dermae.com

SPL UNCLASSIFIED SECTION

Distributed by DERMA E®
Simi Valley, CA 93065, USA

PRINCIPAL DISPLAY PANEL - 113 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SUN CARE
New
&
Improved
FORMULA

DERMA • E

Sun Defense
Clear Zinc
Sunscreen
BROAD SPECTRUM
SPF 30

Mineral Clear Zinc Oxide
Vitamin E & Shea Butter
100% Unscented

spf
30
BODY

DERMATOLOGIST
RECOMMENDED

reef
safe

4 OZ / 113 g

PRINCIPAL DISPLAY PANEL - 113 g Tube Box
PRINCIPAL DISPLAY PANEL - 113 g Tube Box

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54108-0418-1Derma E Sun DefenseSPF 301 in 1 BOXLOTION11
54108-0418-1Derma E Sun DefenseSPF 30113 g in 1 TUBELOTION1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54108-0418DERMA E SUN DEFENSE SPF 30 (ZINC OXIDE AND TITANIUM DIOXIDE) LOTION [DERMA E]1Current NDC, 2 package rows20240713_395b73a4-dae7-49da-9dab-ab622117c8c0.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54108-041854108-0418-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ALUMINUM OXIDELMI26O6933IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL CAPRYLATE/CAPRATE22MCG4RSMRIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
CETEARYL OLIVATE58B69Q84JOIACT
COCO-CAPRYLATE4828G836N6IACT
COCO-GLUCOSIDEICS790225BIACT
DIISOSTEAROYL POLYGLYCERYL-3 DIMER DILINOLEATEG3232Z5S2OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
PANTHENOLWV9CM0O67ZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FYTIC ACID7IGF0S7R8IIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
WATER059QF0KO0RIACT
BETASIZOFIRAN2X51AD1X3TIACT
SHEA BUTTERK49155WL9YIACT
PHYTATE SODIUM88496G1ERLIACT
SORBITAN OLIVATEMDL271E3GRIACT
STEARIC ACID4ELV7Z65APIACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERPN88NW0KPKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT

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
Derma E Sun Defense SPF 30ZINC OXIDE AND TITANIUM DIOXIDEderma e395b73a4-dae7-49da-9dab-ab622117c8c02024-07-12WarningsExact identifier
ndc (package): 54108-0418-1
ndc (product): 54108-0418
ndc11 (package): 54108041801
spl id: 61d20f28-5db0-4155-84f2-10302b84002e
spl set id: 395b73a4-dae7-49da-9dab-ab622117c8c0

Reported adverse events (FAERS/openFDA)#

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