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 210 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rodan and Fields Reverse Brightening Defense Broad Spectrum SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERodan & Fields Beauty, LLCafa2d42e-b54d-4843-b313-0c44fe5c5d522025-06-06WarningsExact identifier
application number: M020
1000 Roses CC Color Plus Correct Sheer Tan SPF 30ZINC OXIDEAndalou naturals9314e4fc-ba3e-480e-a005-b8928130ed702025-06-06WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Face Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC3169bf3b-a5a8-4c3e-a182-9f24f8ade3ac2025-06-05WarningsExact identifier
application number: M020
Body Glove Sunscreen SPF 30ZINC OXIDE, TITANIUM DIOXIDESCUBASCREEN LLC1d7a960c-4387-44dc-8d4e-881e21a8ae2e2025-06-05WarningsExact identifier
application number: M020
Vacation Classic Mini Whip SPF 30 Broad Spectrum SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.36d65cb2-c2e7-06d7-e063-6394a90a38222025-06-05WarningsExact identifier
application number: M020
Vacation Classic Whip SPF 50 Broad Spectrum SPF 50HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.36d747fb-b973-5611-e063-6394a90ac6612025-06-05WarningsExact identifier
application number: M020
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d7c8b3-554f-78d9-e063-6394a90a80f32025-06-05Exact identifier
application number: M020
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d80422-943f-3aba-e063-6294a90afb592025-06-05Exact identifier
application number: M020
Mineral Creme SPF 50 Mineral Creme SPF 50 Broad Spectrum UVA-UVB Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesf8e178d6-058c-462a-8e59-6721f28ad0402025-06-05WarningsExact identifier
application number: M020
Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesadcd6881-fa25-4312-95e5-5b47102aa6b92025-06-05WarningsExact identifier
application number: M020
Mineral Moisture Defense SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences05ad73f3-a4e8-4f78-8212-3e8e3bda988c2025-06-05WarningsExact identifier
application number: M020
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences6ce602bb-c1f4-43c1-ae61-0f05d7952db32025-06-05WarningsExact identifier
application number: M020
Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesb8f08778-7e5e-4341-9a24-1ce57c6525c72025-06-05WarningsExact identifier
application number: M020
Quick Dry Body Broad Spectrum SPF40 Sunscreen UVA-UVB Sunscreen with SolSci-XAVOBENZONE, OCTISALATE, AND OCTOCRYLENEMDSolarSciences812caa99-1e1e-4ab8-9f9a-fb3384c684dd2025-06-05WarningsExact identifier
application number: M020
MD Daily Perfecting Moisturizer SPF 30. SPF 30 Broad Spectrum Sunscreen UVA-UVBAVOBENZONE, OCTOCRYLENE, AND OCTISALATEMDSolarSciencesba918886-d277-487a-be3b-bbe3e24343ad2025-06-05WarningsExact identifier
application number: M020
Gleam plus Glow SPF 50. SPF 50 Broad Spectrum Sunscreen UVA-UVB Sheer Glow TintAVOBENZONE, OCTISALATE, AND OCTOCRYLENEMDSolarSciences3e392af6-1401-4a2f-9ba4-e43f0fd0fca12025-06-05WarningsExact identifier
application number: M020
Tint plus Tone SPF 50. SPF 50 Broad Spectrum Sunscreen Sheer Tinted MoisturizerAVOBENZONE, OCTISALATE, AND OCTOCRYLENEMDSolarSciences51bd8962-e85a-4964-9337-2ded6b7d8ac82025-06-05WarningsExact identifier
application number: M020
Hydrating Sheer Lip Balm SPF 30 -Crystal Broad Spectrum SPF 30 UVA-UVB SunscreenAVOBENZONE, OCTISALATE, AND HOMOSALATEMDSolarSciences0f23441c-2399-4a72-9f0a-420d25db78af2025-06-05WarningsExact identifier
application number: M020
Vacation Classic Whip SPF 30 Broad Spectrum SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.36da165b-bc68-24ff-e063-6294a90a304f2025-06-05WarningsExact identifier
application number: M020
Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDENemah, Inc.36da2d94-fa90-b145-e063-6394a90a58542025-06-05WarningsExact 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