FDA.reportPublic FDA data

Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15

Product NDC
68828-003
11-digit product format
688280003
Labeler code
68828
Product ID
68828-003_42d81048-d0fd-6bb2-e063-6294a90aacb6
Type
HUMAN OTC DRUG
Nonproprietary name
avobenzone, homosalate, octisalate, octocrylene
Dosage form
CREAM
Route
TOPICAL
Labeler
Distribuidora Comercial Jafra, S.A. de C.V.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
3; 5; 5; 7 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68828-00368828-003-02DDiscontinued by firm2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68828-00368828-003-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68828-00368828-003-02DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100mL
HOMOSALATE5 g/100mL
OCTISALATE5 g/100mL
OCTOCRYLENE7 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
865057ce-f617-4232-a60e-e23c120b0a73Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-003-01Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 1575 mL in 1 TUBECREAM757
68828-003-01Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 151 in 1 CARTONCREAM17
68828-003-02Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 151 in 1 CARTONCREAM17
68828-003-02Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 157 mL in 1 TUBECREAM77

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-003SPA NIACINAMIDE AND VITAMIN E HAND CREAM BROAD SPECTRUM SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [DISTRIBUIDORA COMERCIAL JAFRA, S.A. DE C.V.]5Current NDC, Legacy NDC, 4 package rows20250104_865057ce-f617-4232-a60e-e23c120b0a73.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 61 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Broad Spectrum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.c76f5639-bd0f-4987-8c70-224ee33bbbad2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.8795b9a7-1938-4dd9-92ad-3c044feae1da2026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEMeijer, Inc.3f8bad95-8071-47b1-88a7-3a3f09f097b52026-02-24Warnings, Adverse reactionsExact identifier
application number: M020
UV RESTORE FACE SERUM SUNSCREEN SPF 50AVOBENZONE, HOMOSALATE, OCTISALATEBETTER INNOVATION LTD4b9a881a-835b-ef0c-e063-6394a90a94af2026-02-24WarningsExact identifier
application number: M020
MISTINE UV DEFENSE FACE MOISTURIZER SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBETTER INVENTION LTD4b9a9303-662f-9614-e063-6294a90a6b512026-02-24WarningsExact identifier
application number: M020
SANTAL BLOOM SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENSaltair Body LLC4b9ac780-ef7d-42fc-e063-6394a90ad62f2026-02-24WarningsExact identifier
application number: M020
PINK BEACH SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENSaltair Body LLC4b9b36a6-4da9-8439-e063-6394a90aa86b2026-02-24WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEShiseido Americas Corporationb93f10dc-193d-4cda-94b6-3f0e54d89f212026-02-23WarningsExact identifier
application number: M020
cle de peau BEAUTE ADVANCED PROTECTIVE DAYAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporation710975d8-43bf-40b9-82c2-d4dc2988956d2026-02-23WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR MINERALTITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION5e31eee8-6532-47ea-99fc-22418791804b2026-02-23WarningsExact identifier
application number: M020
Eryfotona AgelessZINC OXIDEISDIN Corp.a58ac2ed-31b7-4a86-83ca-7630b0c9ea6f2026-02-23WarningsExact identifier
application number: M020
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
application number: M020
Beauty HydratingHOMOSALATE, ZINC OXIDEMeijer, Inc.69b72139-757f-476d-99d2-33f5524c41d22026-02-19Warnings, Adverse reactionsExact identifier
application number: M020
daily moisturizerAVBENZONE, OCTISALATE, OCTOCRYLENEMeijer, Inc.6d301146-46e0-445c-b14e-3ec8ce76cb452026-02-19Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMeijer, Inc.e9f4a2bb-d21e-4b38-9a37-23c23c8ad8572026-02-19Warnings, Adverse reactionsExact identifier
application number: M020
Inkeeze Tattoo Products Hi-Definition Tattoo Sunscreen SPF 50 Coconut ScentAVOBENZONE, OCTISALATE, OCTOCRYLENEInk-eeze3f759bec-4e33-46fa-a800-fa3a17d63df92026-02-19WarningsExact identifier
application number: M020
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
application number: M020
e.l.f. Best and Obsessed Skincare SetAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEe.l.f. Cosmetics, Inc.4b1c1150-5ac5-4a8b-e063-6394a90a54102026-02-18WarningsExact identifier
application number: M020
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
application number: M020
Degree ClinicalCOOL RUSH INVISIBLE SOLID 96H ANTIPERSPIRANT DEODORANTConopco Inc. d/b/a/ Unilever4b1f9fd3-3c49-9a98-e063-6294a90a20e02026-02-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68828-003-01688280003011 TUBE in 1 CARTON (68828-003-01) / 75 mL in 1 TUBE1 tube2022-06-010000-00-00NoNoCurrent
68828-003-02688280003021 TUBE in 1 CARTON (68828-003-02) > 7 mL in 1 TUBE1 tube2022-06-010000-00-00NoNoCurrent