Home NDC 68828-003 Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15
Product NDC 68828-003
11-digit product format 688280003
Labeler code 68828
Product ID 68828-003_42d81048-d0fd-6bb2-e063-6294a90aacb6
Type HUMAN OTC DRUG
Nonproprietary name avobenzone, homosalate, octisalate, octocrylene
Dosage form CREAM
Route TOPICAL
Labeler Distribuidora Comercial Jafra, S.A. de C.V.
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-06-01
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 3; 5; 5; 7 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 68828-003 68828-003-02 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 68828-003 68828-003-02 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3 g/100mL HOMOSALATE 5 g/100mL OCTISALATE 5 g/100mL OCTOCRYLENE 7 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68828-003-01 Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15 75 mL in 1 TUBE CREAM 75 7 68828-003-01 Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15 1 in 1 CARTON CREAM 1 7 68828-003-02 Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15 1 in 1 CARTON CREAM 1 7 68828-003-02 Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15 7 mL in 1 TUBE CREAM 7 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68828-003 SPA NIACINAMIDE AND VITAMIN E HAND CREAM BROAD SPECTRUM SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [DISTRIBUIDORA COMERCIAL JAFRA, S.A. DE C.V.] 5 Current NDC, Legacy NDC, 4 package rows 20250104_865057ce-f617-4232-a60e-e23c120b0a73.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 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Naked Sundays PoutScreen Plumping Lip Treatment Caramel Latte 10mL LIP TREATMENT NAKED SUNDAYS PTY LTD 2499e14a-c14f-ea13-e063-6394a90a62f5 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays PoutScreen Plumping Lip Treatment Cotton Candy 10mL LIP TREATMENT NAKED SUNDAYS PTY LTD 24a7bee2-3802-4786-e063-6294a90a6ab5 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays PoutScreen Plumping Lip Treatment VANILLA CONFETTI 10mL LIP TREATMENT NAKED SUNDAYS PTY LTD 24aa19c8-86d9-c691-e063-6394a90a691e 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays PoutScreen Plumping Lip Treatment Marshmallow 10mL LIP TREATMENT NAKED SUNDAYS PTY LTD 24a98d3d-f830-9614-e063-6394a90aa7d1 2025-03-22 Warnings Exact identifier application number: M020 SPF50 SHEER GLOW BALM CHAMPAGNE 9g ZINC OXIDE 22.75% NAKED SUNDAY PTY LTD fbfb871b-460f-271a-e053-6394a90acad2 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays Glow Balm Mineral Peptide Stick Broad Spectrum SPF50 Bronze 8g ZINC OXIDE NAKED SUNDAYS PTY LTD 2f42d22a-983e-d304-e063-6294a90a3719 2025-03-22 Warnings Exact identifier application number: M020 SPF50 SHEER GLOW BALM ROSE 9g ZINC OXIDE 22.75% NAKED SUNDAY PTY LTD fbfbd0dd-8961-5fd0-e053-6294a90a5de4 2025-03-22 Warnings Exact identifier application number: M020 Naked Sundays Face Body Clear Glow Sunstick SPF50 SHIMMER Broad Spectrum SPF50 19g AVOBENZONE 3%, HOMOSALATE 10%, OCTISALATE 5% ,OCTOCRYLENE 8% NAKED SUNDAYS PTY LTD 2f47a6c9-dd0a-da94-e063-6294a90a9a45 2025-03-22 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Firming Protocol TITANIUM DIOXIDE AND ZINC OXIDE Obagi Cosmeceuticals LLC 67ba9f32-bbf4-4c14-9e97-08f1cb7d3996 2025-03-21 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Brightening Protocol HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC 2f75ebf7-d6b6-45c6-ad5b-61739d260ff7 2025-03-21 Warnings Exact identifier application number: M020 Hello Kitty Fun Broad Spectrum SPF 40 ZINC OXIDE The Creme Shop Inc 30d37581-122c-ec92-e063-6294a90ab425 2025-03-21 Warnings Exact identifier application number: M020 Hello Kitty Sunny Days Broad Spectrum SPF 40 ZINC OXIDE The Creme Shop Inc 30d3ed8c-f424-8d95-e063-6394a90a0cbc 2025-03-21 Warnings Exact identifier application number: M020 Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. c7142781-fa57-43e5-9436-cb29dd03a669 2025-03-21 Warnings Exact identifier application number: M020 SHISEIDO ULTIMATE SUN PROTECTOR AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE SHISEIDO AMERICAS CORPORATION 00ec7d9c-8550-45ce-8d0a-ef2caf84f98d 2025-03-21 Warnings Exact identifier application number: M020 Obagi Skintrinsiq Clarifiying Protocol SALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDE Obagi Cosmeceuticals LLC 08ba9ea8-73fd-472b-9cc4-67df167352ec 2025-03-21 Warnings Exact identifier application number: M020 Aveeno Kids Continuous Protection Sensitive Skin Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 3e51da46-6a81-4b74-b16e-3fc298a4ba59 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 2d2c58e2-0d15-4383-adae-12fc17b8ea50 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Kenvue Brands LLC 1907126c-fd95-86e8-e063-6394a90a23ca 2025-03-20 Warnings Exact identifier application number: M020 Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus ZINC OXIDE Kenvue Brands LLC 4504a10d-6130-4ec5-823a-ab970709e6d7 2025-03-20 Warnings Exact identifier application number: M020 Vertra Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Eai-jr 286, Inc 30caf1dd-142d-85d3-e063-6394a90a0c88 2025-03-20 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68828-003-01 68828000301 1 TUBE in 1 CARTON (68828-003-01) / 75 mL in 1 TUBE 1 tube 2022-06-01 0000-00-00 No No Current 68828-003-02 68828000302 1 TUBE in 1 CARTON (68828-003-02) > 7 mL in 1 TUBE 1 tube 2022-06-01 0000-00-00 No No Current