FDA.reportPublic FDA data

Royal Jelly Berry Powerful Lip Care

Product NDC
68828-704
11-digit product format
688280704
Labeler code
68828
Product ID
68828-704_42d8496f-20e8-0550-e063-6294a90ae42a
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
STICK
Route
TOPICAL
Labeler
Distribuidora Comercial Jafra, S.A. de C.V.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-10-13
Substance
DIMETHICONE
Active strength
2 g/100g
Pharmacologic classes
Skin Barrier Activity [PE]
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
Royal Jelly Berry Powerful Lip Care
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
09323fbe-76b5-48c6-80a7-c35b64110a7dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68828-704-01Royal Jelly Berry Powerful Lip Care3.7 g in 1 CYLINDERSTICK3.76
68828-704-02Royal Jelly Berry Powerful Lip Care1 in 1 CARTONSTICK16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68828-704ROYAL JELLY BERRY POWERFUL LIP CARE (DIMETHICONE) STICK [DISTRIBUIDORA COMERCIAL JAFRA, S.A. DE C.V.]5Current NDC, Legacy NDC, 2 package rows20250104_09323fbe-76b5-48c6-80a7-c35b64110a7d.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 36 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JAFRA Fruteria Coco Fresco Lip BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.9895a320-8a74-4b27-9bf1-4b492f89888c2025-10-21WarningsExact identifier
application number: M016
JAFRA Fruteria So CitricoDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.a68d6cda-2268-440a-9ca6-677c4e3ea0e72025-10-21WarningsExact identifier
application number: M016
JAFRA Fruteria Very Verde Lip BalmDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.4f0de70b-7ebe-4381-9b46-d5b334f426e02025-10-21WarningsExact identifier
application number: M016
Gelmicin Hydrocortisone with AloeHYDROCORTISONEUnited Exchange Corp.bb64eca4-799d-4711-e053-2995a90af4032025-10-21WarningsExact identifier
application number: M016
QuadrydernHYDROCORTISONEProductos Zapotol Corpa087ad4d-9a65-19c3-e053-2995a90ab3412025-10-21WarningsExact identifier
application number: M016
VENROCKROSEMARY OILGuangzhou Oupeng Cosmetics Co., Ltd4156b669-1817-6280-e063-6394a90aaf3a2025-10-17WarningsExact identifier
application number: M016
Gerigentle-Vitamins A and DPETROLATUMGeri-Gentle Corporationc36c74f7-975b-4e4c-99e3-e6921d782c712025-10-17WarningsExact identifier
application number: M016
Seacall Dexamethasone Ointment.DEXAMETHASONE OINTMENTGuangdong Quadrant Ecological Technology Co., Ltd.201adf67-773c-34a2-e063-6394a90ac5252025-10-15WarningsExact identifier
application number: M016
MedlineZINC OXIDEMedline Industries, LPdae45414-7401-9536-e053-2a95a90a0a862025-10-15WarningsExact identifier
application number: M016
Curology Barrier BalmSKIN BARRIER BALMCurology04b2ba38-0f81-be51-e063-6294a90af8212025-10-15WarningsExact identifier
application number: M016
PetroleumWHITE PETROLATUMMedline Industries, LP34f3581f-39ba-4f28-9237-52f3820ab4c02025-10-09WarningsExact identifier
application number: M016
Facial FortressPYRITHIONE ZINCPediatric Solutions, LLCcdd3c52e-4c32-46c1-bdb3-957b164190bb2025-10-08WarningsExact identifier
application number: M016
Happy CappyPYRITHIONE ZINCPediatric Solutions, LLC3d3828d8-ee15-4aff-99d1-a121f0102a002025-10-08WarningsExact identifier
application number: M016
Purforma Advanced Hand Sanitizer 70% AlcoholHAND SANITIZER 70% ALCOHOLSpartan Chemical Company, Inc.06bd825d-914f-5ca7-e063-6394a90aec492025-10-06WarningsExact identifier
application number: M016
Scar Reducer Intensive Herbal and NutrientALLANTOINQuantum, Inc5197f1fa-aae5-406c-97d9-635b8c1a88a82025-10-06WarningsExact identifier
application number: M016
PURE SOL SPF 30 LIP BALM CACOA BUTTERZINC OXIDEBrand 2022b LLC40537561-d334-5859-e063-6394a90a92a72025-10-04WarningsExact identifier
application number: M016
PURE SOL SPF15 Lip Gloss originalZINC OXIDEBrand 2022b LLC4056e49a-2976-38f9-e063-6394a90a786d2025-10-04WarningsExact identifier
application number: M016
PURE SOL SPF15 Lip Gloss Nudie roseZINC OXIDEBrand 2022b LLC4057b0e2-1c31-abae-e063-6294a90a053d2025-10-04WarningsExact identifier
application number: M016
PURE SOL SPF15 Lip Gloss Pink coralZINC OXIDEBrand 2022b LLC405865dd-7d0e-048d-e063-6394a90ab1052025-10-04WarningsExact identifier
application number: M016
HealthWise Medicated Diabetic Foot CreamDIMETHICONE, PETROLATUMVeridian Healthcare164f4cd8-975a-40d5-e063-6394a90ae7d52025-10-02WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68828-704-01688280704013.7 g in 1 CYLINDER3.7 gHistorical
68828-704-02688280704021 CYLINDER in 1 CARTON (68828-704-02) / 3.7 g in 1 CYLINDER (68828-704-01) 1 cylinder2017-10-130000-00-00NoNoCurrent