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 220 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Superactive Moisturizer SPF 50 Brightening SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLC4ff8525a-4526-4acf-86c7-88f1f10732742025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 UnflavoredLIP BALM SPF15LS Promotions Inc3131632d-735c-6688-e063-6294a90a02392025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Chocolate Sundae flavoredLIP BALM SPF15LS Promotions Inc3142f352-ee65-47b5-e063-6394a90ada572025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Pina Colada flavoredLIP BALM SPF15 PINA COLADA FLAVOREDLS Promotions Inc31440153-e7ca-1327-e063-6294a90a562c2025-03-26WarningsExact identifier
application number: M020
CVS Health Sport 100 ClearAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECVS PHARMACY0a245b1b-eaf6-7011-e063-6294a90ab68f2025-03-26WarningsExact identifier
application number: M020
Lip Balm SPF15 Apple Pie flavoredLIP BALM SPF15 APPLE PIE FLAVOREDLS Promotions Inc3145bd6d-0ece-e9d5-e063-6294a90afb9d2025-03-26WarningsExact identifier
application number: M020
HEB Glow 40 Tinted Sunscreen Face PrimerAVOBENZONE, OCTISALATE, OCTOCRYLENEH.E.B.3146bcd9-d562-9ba6-e063-6294a90a37aa2025-03-26WarningsExact identifier
application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide SunscreenZINC OXIDEH.E.B.3146fb5f-1fb5-f09f-e063-6294a90a62062025-03-26WarningsExact identifier
application number: M020
HEB 50 Glow Body Oil SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B.31473cc9-08f5-39e3-e063-6294a90aa4992025-03-26WarningsExact identifier
application number: M020
HEB 50 Clear Mineral Clear Zinc Oxide SunscreenZINC OXIDEH.E.B.314776a8-a562-3dd2-e063-6394a90ab1b92025-03-26WarningsExact identifier
application number: M020
TRADER JOES INVISIBLE BODY SUNSCREEN SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company31478f5a-88f4-4b01-e063-6394a90a04b72025-03-26WarningsExact identifier
application number: M020
TRADER JOES SHIMMER SUNSCREEN BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETrader Joe's Company3147c08f-c3f2-aef1-e063-6294a90a5c442025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Mangonada Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B3147ef18-9029-6d5b-e063-6394a90acee02025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Mexican Vanilla Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B31487bad-a756-9050-e063-6394a90acacc2025-03-26WarningsExact identifier
application number: M020
TRADER JOES DAILY FACIAL MINERAL SUNSCREEN SPF 40ZINC OXIDETrader Joe's Company3148c00f-21bb-c05f-e063-6394a90af0e82025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Chamomile and Lavender Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B314b8147-fe7a-0698-e063-6394a90a872c2025-03-26WarningsExact identifier
application number: M020
HEB SPF 50 Shine Sunscreen with Vitamin C Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEH.E.B314bcf42-ca01-0fa5-e063-6294a90a5fc82025-03-26WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Hydrating SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMurad, LLC1e5d494b-dccf-4ba1-89de-0bb4ba5b8d382025-03-26WarningsExact identifier
application number: M020
Superactive Moisturizer SPF 50 Wrinkle Fighting SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEMurad, LLCac6163fb-dbc1-432f-a590-86d31c93b29b2025-03-26WarningsExact identifier
application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral MediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe17dc640-30e9-441b-a212-ef1508af79442025-03-25WarningsExact 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