FDA.reportPublic FDA data

Derma E Ultra Sheer Mineral Body Sunscreen Mist SPF 30

Manufacturer
Topiderm Inc.
Effective date
2019-04-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:25:35

Label at a glance#

ProductDerma E Ultra Sheer Mineral Body Sunscreen Mist SPF 30
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 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: At least every two-hours. Immediately after swimming, sweating or towel drying. • 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, especial...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 6%, Zinc Oxide 6%

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.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and consult physician

OTC - STOP USE SECTION

if irritation or rash develops.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed, get medical attention or contact poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply liberally 15-minutes before sun exposure.
• Reapply: At least every two-hours. Immediately after swimming, sweating or towel drying.
• 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.
• For children under 6-months, consult a physician.

Other information

SPL UNCLASSIFIED SECTION

• Protect this product from excessive heat and direct sunlight.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, *Camellia Sinensis (Green Tea) Extract, Capryllic/Capric Triglyceride, Caprylyl/Capryl Glucoside,
*Carthamus Tinctorius (Safflower) Oil, Gluconolactone, *Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, *Glycyrrhiza Glabra (Licorice) Extract, *Helianthus Annuus (Sunflower) Oil, Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Lonicera Caprifolium, (Honeysuckle) Extract, Lonicera Japonica (Honeysuckle) Extract, Polyhydroxystearic Acid, Populus Tremuloides Bark Extract, *Punica Granatum (Pomegranate) Extract, Stearic Acid, *Theobroma Cacao (Cocoa) Butter), Tocopherol (Vitamin E), Xanthan Gum. *Certified Organic Ingredients

Questions or comments?

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-04151326-041-00

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL/CAPRYL OLIGOGLUCOSIDEE00JL9G9K0IACT
SAFFLOWER4VBL71TY4YIACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
GLYCERYL 1-UNDECYLENATEB68LJT9544IACT
LICORICE61ZBX54883IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
POPULUS TREMULOIDES BARK5543O0CEIDIACT
POMEGRANATE56687D1Z4DIACT
STEARIC ACID4ELV7Z65APIACT
COCOAD9108TZ9KGIACT
TOCOPHEROLR0ZB2556P8IACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML · Source PDF

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
0721544c-ebb2-1ac2-e063-6394a90abd485ac54ebb-dfdc-45cd-9c4b-037bb191ab212023-10-07WarningsExact identifier
spl set id: 5ac54ebb-dfdc-45cd-9c4b-037bb191ab21

Reported adverse events (FAERS/openFDA)#

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