FDA.reportPublic FDA data

Derma E Vitamin C Weightless Moisturizer

Manufacturer
derma e | Topiderm, Inc. | Topiderm, Inc
Effective date
2024-05-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:58

Label at a glance#

ProductDerma E Vitamin C Weightless Moisturizer SPF 45
Active ingredientZINC OXIDE
Label structure11 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

shake well 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 s...

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 20%

Purpose

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

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

  • shake well
  • 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

Apium Gravelones (Celery) Seed Extract, Aspalathus Linearis (Rooibos) Leaf Extract, Caprylic/Capric Triglyceride, Cocoglycerides, Diethylhexyl Succinate, Ethylhexylglycerin, Ethylhexyl Olivate, Glycerin, Isostearic Acid, Jojoba Esters, Lauryl Glucoside, Lecithin, Linum Usitatissimum (Linseed) Seed Extract, Natural Fragrance Oil, Niacinamide, Panthenol, Phenoxyethanol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Purified Water, Sodium Ascorbyl Phosphate, Sodium Carboxymethyl Starch, Sodium Phytate, Sorbitan Trioleate, Tetrahexyldecyl Ascorbate, Titanium Dioxide, Tocopheryl Acetate Vitamin E), 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 - 60 mL Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VITAMIN C

• 100% VEGAN • SOY-FREE •
SPF 45
CRUELTY-FREE

DERMA•E

Vitamin C
Weightless
Moisturizer

BROAD SPECTRUM
SPF 45

Rooibos
Vitamins B3 & E

prime and brighten

• DERMATOLOGIST •
RECOMMENDED

2 FL OZ / 60 mL

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Box
PRINCIPAL DISPLAY PANEL - 60 mL Bottle Box

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54108-0359-1Derma E Vitamin C Weightless Moisturizer SPF 4560 mL in 1 BOTTLELOTION601
54108-0359-1Derma E Vitamin C Weightless Moisturizer SPF 451 in 1 BOXLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54108-0359DERMA E VITAMIN C WEIGHTLESS MOISTURIZER SPF 45 (ZINC OXIDE) LOTION [DERMA E]1Current NDC, 2 package rows20240526_a3b404a6-e4b1-4c08-a8ef-77446dd2e411.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
54108-035954108-0359-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
DIETHYLHEXYL SUCCINATE69W9UMG3P8IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ETHYLHEXYL OLIVATEHTC7G3S2PVIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
COCO-GLYCERIDESISE9I7DNUGIACT
GLYCERINPDC6A3C0OXIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PHYTATE SODIUM88496G1ERLIACT
NIACINAMIDE25X51I8RD4IACT
PANTHENOLWV9CM0O67ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FRAGRANCE 135765EM498GW35IACT
XANTHAN GUMTTV12P4NEEIACT
ASPALATHUS LINEARIS LEAFH7UGK1GJCUIACT
SORBITAN TRIOLEATEQE6F49RPJ1IACT
HYDROLYZED JOJOBA ESTERS (ACID FORM)UDR641JW8WIACT
SODIUM ASCORBYL PHOSPHATE836SJG51DRIACT
CELERY SEED1G1EAA320LIACT
FLAX SEED4110YT348CIACT

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 Vitamin C Weightless Moisturizer SPF 45ZINC OXIDEderma ea3b404a6-e4b1-4c08-a8ef-77446dd2e4112024-05-24WarningsExact identifier
ndc (package): 54108-0359-1
ndc (product): 54108-0359
ndc11 (package): 54108035901
spl id: 70986927-3c53-4c5f-8d8a-a9b6fd36da04
spl set id: a3b404a6-e4b1-4c08-a8ef-77446dd2e411

Reported adverse events (FAERS/openFDA)#

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