FDA.reportPublic FDA data

Derma E Sun Drops SPF 30

Manufacturer
derma e | Topiderm, Inc.
Effective date
2026-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-11 05:10:26

Label at a glance#

ProductDerma E Sun Drops SPF 30
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburns 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

Shake well before each use Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours when exposed to sun 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 a Broad Spectrum SPF value of 15 or higher and other sun ...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 22%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburns
  • 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 - 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

  • Shake well before each use
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours when exposed to sun
  • 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 a Broad Spectrum 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 For children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Caprylic/Capric Triglyceride, Propanediol, Polyglyceryl-10-Stearate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Glyceryl Hydrogenated Rosinate, Polyglyceryl-2 Dipolyhydroxystearate, Glyceryl Caprylate, Jojoba Esters, Isostearic Acid, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Aloe Barbadensis Leaf Juice, Tapioca Starch, Glycerin, Capryloyl Glycerin/Sebacic Acid Copolymer, Lecithin, Sorbitan Sesquioleate, Tocopherol, Bisabolol, Caprylhydroxamic Acid, Sodium Phytate.

Other information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun.

SPL UNCLASSIFIED SECTION

Distributed by DERMA E®
North Amityville, NY 11701, USA

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ESSENTIALS

DERMA • E

Daily Sun Serum
SPF 30

broad spectrum UVA/UVB
mineral sunscreen lotion

DERMATOLOGIST
RECOMMENDED

50 mL
NPN #80147356

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54108-148854108-1488-1

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
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PROPANEDIOL5965N8W85TIACT
POLYGLYCERYL-10 STEARATE90TF85HH91IACT
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE687U3PEB2YIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
ISOSTEARIC ACIDX33R8U0062IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
ALOE VERA LEAF JUICERUE8E6T4NBIACT
STARCH, TAPIOCA24SC3U704IIACT
GLYCERINPDC6A3C0OXIACT
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S)N7YC58165TIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
PHYTATE SODIUM88496G1ERLIACT
GLYCERYL ROSINATESD112V492JIACT

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 Drops SPF 30ZINC OXIDEderma e76c29f24-e0d9-4235-b278-96e609bc58db2026-06-04WarningsExact identifier
ndc (package): 54108-1488-1
ndc (product): 54108-1488
ndc11 (package): 54108148801
spl id: e79086ca-0657-497a-bb2b-204a997eaf04
spl set id: 76c29f24-e0d9-4235-b278-96e609bc58db

Reported adverse events (FAERS/openFDA)#

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