FDA.reportPublic FDA data

NDC 67938-2075-2 - PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67938-2075
Requested NDC
67938-2075-2
Package NDCs from labels
67938-2075-2, 67938-2075-1
Manufacturer
ELIZABETH ARDEN, INC
Effective date
2017-02-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TITANIUM DIOXIDE, ZINC OXIDE - ELIZABETH ARDEN, INCELIZABETH ARDEN, INC2017-02-01HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-2075-12020-09-27C16284748780-1ab0e2407-27dc-f274-e053-dbdaa90a6471Drug Facts
67938-2075-12020-09-25C16284748780-1ab0e2407-27dc-f274-e053-dbdaa90a6471Drug Facts
67938-2075-12020-07-22C16284748780-1ab0e2407-27dc-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-2075-1PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN1 in 1 BOXLOTION11
67938-2075-2PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN50 mL in 1 BOTTLELOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-2075PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) LOTION [ELIZABETH ARDEN, INC]1Legacy NDC, 2 package rows20170210_6b1920aa-ec6a-4c8b-b8b8-2c621f959e94.zip

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 9 of 310 · 6,191 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ceile tint PROTECT tinted serum SPF 50 Medium TanCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM TANLE COSMETICS INC58547e38-ae84-82ee-e063-6394a90a27d62026-08-05WarningsExact identifier
unii: SOI2LOH54Z
Ceile tint PROTECT tinted serum SPF 50 TanCEILE TINT PROTECT TINTED SERUM SPF 50 TANLE COSMETICS INC58548331-38cd-8668-e063-6394a90a33622026-08-05WarningsExact identifier
unii: SOI2LOH54Z
Ceile tint PROTECT tinted serum SPF 50 Medium HoneyCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM HONEYLE COSMETICS INC5854861a-376d-8825-e063-6394a90a8aab2026-08-05WarningsExact identifier
unii: SOI2LOH54Z
Ceile tint PROTECT tinted serum SPF 50 HoneyCEILE TINT PROTECT TINTED SERUM SPF 50 HONEYLE COSMETICS INC585488c5-fac5-212f-e063-6294a90a00ff2026-08-05WarningsExact identifier
unii: SOI2LOH54Z
Ceile tint PROTECT tinted serum SPF 50 Medium RichCEILE TINT PROTECT TINTED SERUM SPF 50 MEDIUM RICHLE COSMETICS INC585488af-d14f-8d71-e063-6394a90ac4f02026-08-05WarningsExact identifier
unii: SOI2LOH54Z
Ceile tint PROTECT tinted serum SPF 50 RichCEILE TINT PROTECT TINTED SERUM SPF 50 RICHLE COSMETICS INC58548e6d-9c82-249c-e063-6294a90a11ad2026-08-05WarningsExact identifier
unii: SOI2LOH54Z
Gencare-Gas ReliefSIMETHICONE 180 MGPIONEER LIFE SCIENCES, LLCb7f2d5db-c1b7-4c01-8ee6-017e4b9f14252026-08-04WarningsExact identifier
unii: 92RU3N3Y1O
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
unii: 9E8X80D2L0
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
ROROBELL WAWA Gum Care ToothHYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEROROBELL582204ef-b784-0d95-e063-6394a90a38d22026-08-03WarningsExact identifier
unii: 9E8X80D2L0
PROCUREZINC OXIDETWIN MED, LLCe68ae97e-668e-31c2-e053-2995a90ab4d32026-08-03WarningsExact identifier
unii: SOI2LOH54Z
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
SimethiconeSIMETHICONEAphena Pharma Solutions - Tennessee, LLCda0cc98e-1692-405a-ab81-420d6f9df6de2026-07-31WarningsExact identifier
unii: 92RU3N3Y1O
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
INFANTS GAS RELIEF DROPSSIMETHICONERELIABLE 1 LABORATORIESb479bf22-3469-7916-e053-2995a90addc82026-07-30WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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