emilia

Manufacturer
Emilia Cosmetics Ltd
Effective date
2017-10-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:11:38

Label at a glance#

Productemilia Broad Spectrum
Active ingredientOCTINOXATE
Label structure9 sections

Storage and handling

Other information protect the product in this container from ecessive heat and direct sun

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Octinoxate, 4.0%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

Uses

•helps prevent sunburn

•if used as directedwith other sun protection

measures (see Directions), decreases the risk of

skin cancer and early skin aging caused by the sun.

WARNINGS SECTION

Warnings

For external use only.

Do not use on •damaged or broken skin

When using this product  •keep out of eyes.

Rinse with water to remove

Stop use and ask a doctor  •if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If swallowed, get

medical help or contact a Poison Control Center

right away.

DOSAGE & ADMINISTRATION SECTION

Directions

•apply liberally 15 minutes before sun exposure

•reapply at least every two hours

•use water resistant sunscreen if swimming or sweating

•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 a

Broad Spectrum SPF value 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-sleeved shirts, pants, hats and sunglasses

STORAGE AND HANDLING SECTION

Other information protect the product in this

container from ecessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive ingredients: water, titanium dioxide, potassium cetyl phosphate,

cyclopentasiloxane, talc, glyceryl myristate, butylene glycol,

propandiol, behenyl alcohol, C12-15 alkyl benzoate,

caprylic/capric triglyceride, isohexadecane, isononyl isononanoate,

boron nitride, microcrystalline cellulose, cellulose gum, glycerin, sodium lactate,

lactic acid, TEA-lactate, serine, urea, sorbitol, sodium chloride, allantoin,

phenoxyethanol, ethylhexylglycerin, nylon-12, iron oxides, ammonium

acryloyldimethyltaurate/

VP copolymer, fragrance, triethanolamine,

caffeine, disodium EDTA, tocopheryl acetate (vitamin E), opuntia streptacantha

stem extract, lepidium sativum sprout extract, lecithin, hyaluronic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43219-004-152020-02-13C16284748780-19d75b9d1-0fea-f424-e053-dadaa90a57cecc08834f-6af7-4c4d-8ba0-88d77db8d36a
43219-004-152020-01-31C16284748780-19d75b9d1-0fea-f424-e053-dadaa90a57cecc08834f-6af7-4c4d-8ba0-88d77db8d36a

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43219-00443219-004-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

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
832a0e91-1007-4fb9-aa16-fd456c051c29cc08834f-6af7-4c4d-8ba0-88d77db8d36a2017-10-04WarningsExact identifier
spl id: 832a0e91-1007-4fb9-aa16-fd456c051c29
spl set id: cc08834f-6af7-4c4d-8ba0-88d77db8d36a

Reported adverse events (FAERS/openFDA)#

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