FDA.reportPublic FDA data

JAFRA ROYAL REVITALIZE 4 TUBE SET

Product NDC
68828-522
11-digit product format
688280522
Labeler code
68828
Product ID
68828-522_2b45ed23-0c0b-1b2b-e063-6294a90adcc5
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form
KIT
Route
TOPICAL
Labeler
Distribuidora Comercial Jafra, S.A. de C.V.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-20
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
JAFRA ROYAL REVITALIZE 4 TUBE SET
Listing expiration
2026-12-31

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b4a0d6ab-50a7-43e7-9d7e-a4c01d7eca98Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
68828-522-01JAFRA ROYAL REVITALIZE 4 TUBE SET1 in 1 KITKIT12
68828-523-01JAFRA ROYAL REVITALIZE 4 TUBE SET14 mL in 1 TUBELOTION14 mL5 g in 100mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-522JAFRA ROYAL REVITALIZE 4 TUBE SET (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) KIT [DISTRIBUIDORA COMERCIAL JAFRA, S.A. DE C.V.]2Current NDC, 2 package rows20250112_b4a0d6ab-50a7-43e7-9d7e-a4c01d7eca98.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 196 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Earth Mama Tinted Mineral Sunscreen SPF 40ZINC OXIDEEleeo Brands LLC3c455d29-df4e-f4d5-e063-6394a90a97ba2025-08-13WarningsExact identifier
application number: M020
Baby Bum Mineral 50 SunscreenTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3c470ff8-37d6-a729-e063-6294a90aa5252025-08-13WarningsExact identifier
application number: M020
Sun Bum 50 Mineral Sunscreen 1 OZZINC OXIDESun Bum, LLC3c483d04-8942-5269-e063-6294a90a38812025-08-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE/OCTOCRYLENE/OXYBENZONEEdgewell Personal Care Brands LLC3c49c623-47c6-4dc9-e063-6294a90a00962025-08-13WarningsExact identifier
application number: M020
100% MINERAL SUNSCREEN100% MINERAL SUNSCREENGuangzhou Pallas Cosmetics Co.,Ltd.3c4a3b41-9183-3835-e063-6394a90aea612025-08-13WarningsExact identifier
application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 FAIROCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4443d4e6-bdc9-4547-9189-e94e9e0bdd2d2025-08-12WarningsExact identifier
application number: M020
ERBORIAN CC Red Correct Color Correcting SPF 25OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&La6cd16cc-5fe3-41b5-b724-83e469cd4d5e2025-08-12WarningsExact identifier
application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 BRONZEOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L4aa12cf0-0c48-4b40-9c9a-bd50523cce8a2025-08-12WarningsExact identifier
application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 MEDIUMOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L5bdaa149-47aa-40ac-b17a-ea6d290998622025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1dda967c-2d69-8948-e063-6294a90ad2a42025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 15mL with wild Rosella SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD24e9a9b8-41ba-123a-e063-6394a90a73cb2025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 40mL with wild Rosella SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1dd9fe59-9e40-fd06-e063-6394a90a4ca22025-08-12WarningsExact identifier
application number: M020
Coola Anti-Aging Hand Cream SunscreenAVOBENZONE, OCTOCRYLENE, OCTISALATECOOLA LLC3c2fbf10-d68e-c601-e063-6294a90a09a32025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 15mL with Pink Algae SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD24ea340a-06cd-b085-e063-6394a90adff92025-08-12WarningsExact identifier
application number: M020
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.15536331-fec5-4daa-824d-2e32d63e64522025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS PEARL 40mL with Pink Algae SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1ddad045-7703-ea7e-e063-6394a90a2a5a2025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Sheer Tint 15mL SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD0cf45fbf-b257-f16a-e063-6294a90a87942025-08-12WarningsExact identifier
application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Sheer Tint 40mL SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD1ddb1f53-69dd-643a-e063-6394a90ad6002025-08-12WarningsExact identifier
application number: M020
Earth Mama Lady Face Mineral Sunscreen - Medium/Dark Tint Broad Spectrum SPF 40ZINC OXIDEEarth Mama Angel Baby LLC908c41fd-0496-4237-813b-1135e10ae0c52025-08-12WarningsExact identifier
application number: M020
Earth Mama Baby Mineral Sunscreen SPF 40ZINC OXIDEEarth Mama Angel Baby, LLC74475fba-4cdd-4b27-8ea4-646f4016580c2025-08-12WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68828-522-01688280522011 KIT in 1 KIT (68828-522-01) * 7.5 mL in 1 TUBE * 14 mL in 1 TUBE * 14 mL in 1 TUBE (68828-523-01) * 30 mL in 1 TUBE1 kit2024-12-20NoNoCurrent
68828-523-016882805230114 mL in 1 TUBE14 mlHistorical