FDA.reportPublic FDA data

Derma-E Kids Active Sunscreen Spray SPF 50

Manufacturer
Topiderm Inc.
Effective date
2019-04-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:25:37

Label at a glance#

ProductDerma-E Kids Active Sunscreen SPF 50
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 10%, 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

Actinidia Chinensis (Kiwi) Fruit Extract, Aloe Barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Carthamus Tinctorius (Safflower) Oil, Cocos Nucifera (Coconut) Oil, Garcinia Mangostana (Mangosteen) Extract, Hydrogenated Methyl Abietate, Linum Usitatissmum (Linseed) Oil, Lycium Barbarum (Goji) Fruit Extract, Parfum (Fragrance), Punica Granatum (Pomegranate) Extract, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).

Questions or comments?

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51326-04351326-043-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
KIWI FRUIT71ES77LGJCIACT
ALOE VERA LEAFZY81Z83H0XIACT
ASCORBYL PALMITATEQN83US2B0NIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
SAFFLOWER4VBL71TY4YIACT
COCONUT OILQ9L0O73W7LIACT
HYDROGENATED METHYL ABIETATEA23O709X8OIACT
FLAX SEED4110YT348CIACT
LYCIUM BARBARUM FRUIT930626MWDLIACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB

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
07226ee2-9013-6aab-e063-6294a90aa5478f27cb9d-90ca-429c-824d-cda1101d12282023-10-07WarningsExact identifier
spl set id: 8f27cb9d-90ca-429c-824d-cda1101d1228

Reported adverse events (FAERS/openFDA)#

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