FDA.reportPublic FDA data

EB-5 Ultra Light Face Cream (SPF-15)

Manufacturer
Elements Brands, Inc
Effective date
2018-05-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:58:47

Label at a glance#

ProductEB5 Ultra Light Face SPF 15
Active ingredientOCTINOXATE, OCTISALATE, 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 ealy skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: -Limit ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 5%

Octisalate 3%

Zinc Oxide 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 ealy skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

-Limit time in the sun, especially between 10am and 2pm.

-Wear long sleeve shirts, pants, hats and sunglasses.

-For children under 6-months, consult a physician.

Other information

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sunlight.

Other ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aqua (Deionized Water), Avena Sativa (Oat) Kernel Protein, Carbomer, Cetyl Alcohol, Dimethicone, dl-Panthenol, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorbate-20, Potassium Sorbate, Propylene Glycol, Retinyl Palmitate (Vitamin A), Silica, Sodium Hydroxide, Stearic Acid, Tocopheryl Acetate (Vitamin E)

Question or Comments?

OTC - QUESTIONS SECTION

1-800-683-2325 or help@eb5.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
71221-32571221-325-00

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
ALLANTOIN344S277G0ZIACT
WATER059QF0KO0RIACT
OATZ6J799EAJKIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT
PANTHENOLWV9CM0O67ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM HYDROXIDE55X04QC32IIACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
07231284-93a5-4fe5-e063-6294a90af45886b2b866-0cd2-4cfd-87e7-483e0e5742f82023-10-07WarningsExact identifier
spl set id: 86b2b866-0cd2-4cfd-87e7-483e0e5742f8

Reported adverse events (FAERS/openFDA)#

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