FDA.reportPublic FDA data

Derma-E Sensitive 3-in-1 sunscreen 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 00:25:34

Label at a glance#

ProductDerma-E Sensitive 3-in-1 sunscreen SPF 30
Active ingredientOCTOCRYLENE, OCTISALATE, AVOBENZONE
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

Octocrylene 5%, Octisalate 5%,
Avobenzone 3%

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, Aqua (Deionized Water), Betaglucan, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Cetearyl Olivate, Cucumis Sativus (Cucumber) Extract, Daucus Carota Sativa (Carrot) Extract, Dimethicone, Ethylhexylglycerin, Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Hydrolyzed Oat Protein, Phenoxyethanol, Polysorbate-20, Silica, Sodium Hydroxide, Sorbitan Olivate, Stearic Acid, Styrene/Acrylates Copolymer, Xanthan Gum, Zemea (Corn) Propanediol.

Questions or comments?

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Products#

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DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-04051326-040-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARTHAMUS TINCTORIUS SEED OLEOSOMES9S60Q72309IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETEARYL OLIVATE58B69Q84JOIACT
CUCUMBERYY7C30VXJTIACT
CARROTL56Z1JK48BIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
LICORICE61ZBX54883IACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITAN OLIVATEMDL271E3GRIACT
STEARIC ACID4ELV7Z65APIACT
XANTHAN GUMTTV12P4NEEIACT
CORN0N8672707OIACT
PROPANEDIOL5965N8W85TIACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB

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
07226360-bf85-5b02-e063-6294a90ab4f705dc82db-e493-47b5-972f-cfce4b8625362023-10-07WarningsExact identifier
spl set id: 05dc82db-e493-47b5-972f-cfce4b862536

Reported adverse events (FAERS/openFDA)#

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