FDA.reportPublic FDA data

Public Goods

Manufacturer
Emilia Cosmetics Ltd
Effective date
2021-11-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:29:17

Label at a glance#

ProductPublic Goods
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure10 sections

Storage and handling

Other information •protect product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Titanium Dioxide, 7.6%

Zinc Oxide, 4.0%

OTC - PURPOSE SECTION

Purpose

Sunscreen

Sunscreen

INDICATIONS & USAGE SECTION

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.

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 2 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, hatsand sunglasses. 

STORAGE AND HANDLING SECTION

Other information •protect product in this container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive ingredients water, caprylic/capric triglyceride, sesamum

indicum (sesame) seed oil, helianthus annuus (sunflower) seed oil,

glycerin, coco-glucoside, coconut alcohol, ricinus communis (castor)

oil, simmondsia chinensis (jojoba) seed oil, butyrosperum parkii

(shea) butter, microcrystalline cellulose, cellulose gum, arachidyl

alcohol, behenyl alcohol, arachidyl glucoside, phenoxyethanol,

ethylhexylglycerin, xantham gum, PEG-40 stearate,

trimethoxycarpylylsilane, allantoin,tocopheryl acetate (vitamin E),

panthenol (pro-vitamin B5), bisabolol, hippophae rhammnioides oil,

echinacea purpurot extract, avena sativa (oat) extract, chamomilla

recutita (matricaria) flower extract, tilia vulgaris flower extract,

melissa officinalis leaf extract, aspalathus linearis leaf extract

OTC - QUESTIONS SECTION

Questions or comments?  (855) 506-6742

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

332424

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43219-008-032023-06-17C16284748780-19d75b9d0-aac8-f424-e053-dadaa90a57cePublic Goods
43219-008-502023-06-17C16284748780-19d75b9d0-aac8-f424-e053-dadaa90a57cePublic Goods
43219-008-032023-01-30C16284748780-19d75b9d0-aac8-f424-e053-dadaa90a57cePublic Goods
43219-008-502023-01-30C16284748780-19d75b9d0-aac8-f424-e053-dadaa90a57cePublic Goods
43219-008-032020-02-17C16284748780-19d75b9d0-aac8-f424-e053-dadaa90a57cePublic Goods
43219-008-502020-02-17C16284748780-19d75b9d0-aac8-f424-e053-dadaa90a57cePublic Goods
43219-008-032020-01-31C16284748780-19d75b9d0-aac8-f424-e053-dadaa90a57cePublic Goods
43219-008-502020-01-31C16284748780-19d75b9d0-aac8-f424-e053-dadaa90a57cePublic Goods

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43219-00843219-008-50, 43219-008-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SESAME OILQX10HYY4QVIACT
SUNFLOWER OIL3W1JG795YIIACT
GLYCERINPDC6A3C0OXIACT
COCO GLUCOSIDEICS790225BIACT
COCONUT ALCOHOL13F4MW8Y9KIACT
CASTOR OILD5340Y2I9GIACT
JOJOBA OIL724GKU717MIACT
SHEA BUTTERK49155WL9YIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
DOCOSANOL9G1OE216XYIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
XANTHAN GUMTTV12P4NEEIACT
PEG-40 STEARATEECU18C66Q7IACT
TRIMETHOXYCAPRYLYLSILANEFZ07E4LW2MIACT
ALLANTOIN344S277G0ZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PANTHENOLWV9CM0O67ZIACT
LEVOMENOL24WE03BX2TIACT
HIPPOPHAE RHAMNOIDES SEED OILT53SBG6741IACT
ECHINACEA PURPUREA ROOTOS64WTR4KUIACT
OAT BRANKQX236OK4UIACT
CHAMOMILEFGL3685T2XIACT
TILIA X EUROPAEA FLOWERNHV2K1OUDHIACT
MELISSA OFFICINALIS FLOWERING TOP5JQG17B06JIACT
ASPALATHUS LINEARIS LEAFH7UGK1GJCUIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
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
fe530be3-7718-b477-e053-6394a90a4e04fde1e41f-142b-49b2-9eae-bdda5cd098f22023-06-17WarningsExact identifier
spl set id: fde1e41f-142b-49b2-9eae-bdda5cd098f2

Reported adverse events (FAERS/openFDA)#

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