FDA.reportPublic FDA data

Sun Protection Mineral

Manufacturer
derma e | Topiderm, Inc.
Effective date
2026-07-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
weekly-update
Hydrated at
2026-07-17 21:44:09

Label at a glance#

ProductSun Protection Mineral SPF 30
Active ingredientZINC OXIDE
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 Reapply throughout the day 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. we...

Storage and handling

protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 24.5%

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

SPL UNCLASSIFIED SECTION

For external use only

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
  • Reapply throughout the day
  • 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aluminum Starch Octenylsuccinate, Mica, Silica, Lauroyl Lysine, Kaolin, Calcium Carbonate, Caprylic/Capric Triglyceride, CI 77492, Triethoxycaprylylsilane, CI 77491, CI 77499, Bisabolol, Ceramide NP, Ascorbic Acid, Tocopheryl Acetate, Capryloyl Glycine, Undecylenoyl Glycine, Sodium Benzoate, Potassium Sorbate.

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 - 5 g Applicator Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ESSENTIALS

NEW
LOOK!
same
formula

DERMA∙E

Sun Protection
Mineral Powder
SPF 30

PROTECTS + MATTIFIES
24.5% zinc oxide
ceramides

broad spectrum UVA/UVB

DERMATOLOGIST
RECOMMENDED

0.16 OZ / 5 g

Principal Display Panel - 5 g Applicator Box
Principal Display Panel - 5 g Applicator Box

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54108-148754108-1487-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
MICAV8A1AW0880IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
LAUROYL LYSINE113171Q70BIACT
KAOLIN24H4NWX5COIACT
CALCIUM CARBONATEH0G9379FGKIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
.ALPHA.-BISABOLOL, (+)-105S6I733ZIACT
CERAMIDE NP4370DF050BIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
CAPRYLOYL GLYCINE8TY5YO42NJIACT
UNDECYLENOYL GLYCINE4D20464K2JIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
Sun Protection Mineral SPF 30ZINC OXIDEderma ebf6474a7-a21f-49cb-86e6-e5c40dbd34c32026-07-08WarningsExact identifier
ndc (package): 54108-1487-1
ndc (product): 54108-1487
ndc11 (package): 54108148701
spl id: e905665f-0fb6-4e2a-b6f9-ac36538c8235
spl set id: bf6474a7-a21f-49cb-86e6-e5c40dbd34c3

Reported adverse events (FAERS/openFDA)#

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