Home NDC 68828-010 JAFRA Fruteria Coco Fresco Lip Balm
Product NDC 68828-010
11-digit product format 688280010
Labeler code 68828
Product ID 68828-010_41ad5581-5b88-1c8b-e063-6294a90a2ba6
Type HUMAN OTC DRUG
Nonproprietary name DIMETHICONE
Dosage form GEL
Route TOPICAL
Labeler Distribuidora Comercial Jafra, S.A. de C.V.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-06-01
Substance DIMETHICONE
Active strength 1 g/100mL
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 JAFRA Fruteria Coco Fresco Lip Balm
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 1 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68828-010-01 JAFRA Fruteria Coco Fresco Lip Balm 1 in 1 CARTON GEL 1 3 68828-010-01 JAFRA Fruteria Coco Fresco Lip Balm 15 mL in 1 TUBE GEL 15 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68828-010 JAFRA FRUTERIA COCO FRESCO LIP BALM (DIMETHICONE) GEL [DISTRIBUIDORA COMERCIAL JAFRA, S.A. DE C.V.] 2 Current NDC, 2 package rows 20241228_9895a320-8a74-4b27-9bf1-4b492f89888c.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 41 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join terrasil Infection Protection Wound Care ALLANTOIN Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions e98d1d8c-c979-49de-9bd8-cd409efff6de 2025-07-11 Warnings Exact identifier application number: M016 Neosporin Lip Health Overnight Renewal Therapy PETROLATUM Kenvue Brands LLC 0da54fe1-c99f-4a2d-9ee5-2dc24005096c 2025-07-10 Warnings Exact identifier application number: M016 COCOA BUTTER PETROLEUM jelly PETROLATUM Savvy Care & Cosmetics Pvt. Ltd. 397d13f1-3b86-3c76-e063-6394a90a0f24 2025-07-09 Warnings Exact identifier application number: M016 Pipette Eczema COLLOIDAL OATMEAL Pipette LLC 39829827-d801-f5a7-e063-6394a90a024c 2025-07-09 Warnings Exact identifier application number: M016 Zinc Oxide ZINC OXIDE Westminster Pharmaceuticals, LLC 7e045b3a-f33b-4faa-ab9b-2baec6ff7924 2025-07-08 Warnings Exact identifier application number: M016 Desitin Multi-Purpose Healing PETROLATUM Kenvue Brands LLC 30f06dbb-de8c-43ee-b1ed-99ffd59dd3ab 2025-07-07 Warnings Exact identifier application number: M016 Astringent Solution ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE First Nation Group 065c895c-7d86-f1ed-e063-6394a90a3a52 2025-07-07 Warnings Exact identifier application number: M016 Creamy Petroleum PETROLATUM Savvy Care & Cosmetics Pvt Ltd 3916daee-f8d2-e3f0-e063-6294a90a3883 2025-07-04 Warnings Exact identifier application number: M016 Exemax Cream DIMETHICONE, ALLANTOIN PureTek Corporation 38e79055-df84-d314-e063-6394a90ac95f 2025-07-01 Warnings Exact identifier application number: M016 Procure Dimethicone 5% DIMETHICONE Twin Med LLC 38a7e4af-997d-549e-e063-6394a90a0bd6 2025-06-28 Warnings Exact identifier application number: M016 Zinc Oxide ZINC OXIDE OINTMENT Derma Sciences Canada Inc. 37eff762-1ea9-ec66-e063-6394a90a3d10 2025-06-19 Warnings Exact identifier application number: M016 Dr.Johnes SKIN TAG REMOVER SALICYLIC ACID Dr.Johnes LLC b731c55e-31ee-429f-8432-fac7c5718d83 2025-06-18 Warnings Exact identifier application number: M016 Dr. Johne SKIN TAG REMOVER SALICYLIC ACID Dr.Johnes LLC 6c5adc3c-9d45-449a-ad42-f9571851cd18 2025-06-18 Warnings Exact identifier application number: M016 THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal OATMEAL THERAPLEX, LLC e51aa467-ffe7-4c6b-8588-6df8592596d4 2025-06-16 Warnings Exact identifier application number: M016 ZIIDII Wild Yam Cream WILD YAM Guangzhou Haishi Biological Technology Co., Ltd. 3733154a-4884-9988-e063-6294a90aa78c 2025-06-10 Warnings Exact identifier application number: M016 Aveeno Calm Plus Restore Skin Therapy Balm COLLOIDAL OATMEAL Kenvue Brands LLC dbe7a2cc-9c21-2a48-e053-2a95a90a54e2 2025-06-04 Warnings Exact identifier application number: M016 Petroleum Jelly WHITE PETROLATUM WALGREENS 2017113f-d192-5fbb-e063-6294a90a83b0 2025-05-31 Warnings Exact identifier application number: M016 AHHH Bite Relief SODIUM BICARBONATE 78271 25a1e070-9228-4ec9-e063-6294a90ad78d 2025-05-27 Warnings Exact identifier application number: M016 SupreH Bee Venom Skin Tag Treatment Liquid SUPREH BEE VENOM SKIN TAG REMOVER LIQUID Shenzhen Xinxin Yunhai Technology Co., Ltd. 35ca9836-917a-b0ac-e063-6294a90a28a2 2025-05-23 Warnings Exact identifier application number: M016 terrasil Diabetics Ulcer and Bed Sore Relief ALLANTOIN Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions 35d2738c-dacf-7309-e063-6294a90aab4c 2025-05-23 Warnings Exact identifier application number: M016
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68828-010-01 68828001001 1 TUBE in 1 CARTON (68828-010-01) / 15 mL in 1 TUBE 1 tube 2023-06-01 No No Current