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 185 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ELROEL Pang Pang Sun Cushion Plus ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE MONOGLOT HOLDINGS Inc. 5ffaad65-f0b2-416a-b0a3-b92e880641e4 2025-09-18 Warnings Exact identifier application number: M020 e.l.f. Camo CC Cream SPF 30 Fair 125 C HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE e.l.f. Cosmetics, Inc. 407f9c0d-31c6-f5bb-e063-6394a90a4db4 2025-09-18 Warnings Exact identifier application number: M020 Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC 1630feee-7e0d-c6f4-e063-6294a90a7b1c 2025-09-17 Warnings Exact identifier application number: M020 Guise Tinted Drops ZINC OXIDE Donis Men LLC 3f039049-5004-2888-e063-6294a90a5150 2025-09-17 Warnings Exact identifier application number: M020 ONE SIZE ON TIL DAWN ONE SIZE ON TIL DAWN Pogi Beauty LLC 3f05d90b-9274-4d21-e063-6294a90a8485 2025-09-17 Warnings Exact identifier application number: M020 PUR 4-in-1 Skin Tint DP3 ZINC OXIDE PUR Minerals 3f073413-b314-e5da-e063-6394a90a9ab4 2025-09-17 Warnings Exact identifier application number: M020 e.l.f. Hydrating Camo CC Cream SPF30 Fair 100 W HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE e.l.f. Cosmetics, Inc. 3fa7ef54-2c4d-9883-e063-6294a90a8d88 2025-09-17 Warnings Exact identifier application number: M020 CVS SPF 50 Face Sunscreen TITANIUM DIOXIDE, ZINC OXIDE CVS 26a69a47-947a-a478-e063-6394a90aa468 2025-09-16 Warnings Exact identifier application number: M020 SkinSuit TM 3 in 1 Moisturizer SPF 50 ZINC OXIDE Skin Authority LLC 5eb27be9-9e80-4f4a-b193-b918d831555d 2025-09-15 Warnings Exact identifier application number: M020 Sun and Honey Tallow Sunscreen SPF 30 ZINC OXIDE Amara Ventures 3eda8a70-7c9e-e920-e063-6394a90a85a2 2025-09-15 Warnings Exact identifier application number: M020 Klein Tools Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE KLEIN TOOLS, INC. 3edcc26a-d960-3fa8-e063-6394a90ab703 2025-09-15 Warnings Exact identifier application number: M020 Klein Tools Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTOCRYLENE KLEIN TOOLS, INC. 3ede5e54-4c9f-02f7-e063-6294a90a9df6 2025-09-15 Warnings Exact identifier application number: M020 I.C. Industrial Sunscreen ZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATE R & R Lotion, Inc b89d687a-7b36-4643-9817-765d4710ca60 2025-09-15 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 97795f0e-d867-4e17-b7c9-ede08e7df70c 2025-09-12 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 36N Deep ZINC OXIDE DOLCE & GABBANA BEAUTY S.R.L. 2d05659c-57d2-4faf-ab67-1b8d68945aed 2025-09-12 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 37W Deep ZINC OXIDE DOLCE & GABBANA BEAUTY S.R.L. 5ff2b9e4-a778-4667-8c3c-3561317b374a 2025-09-12 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 39N Deep ZINC OXIDE DOLCE & GABBANA BEAUTY S.R.L. bc4f909f-3e2c-4fd7-a129-3c2fac8259f0 2025-09-12 Warnings Exact identifier application number: M020 Dolce and Gabbana Blueberry Nutri Tint SPF 20 40C Deep ZINC OXIDE DOLCE & GABBANA BEAUTY S.R.L. 2dd9a30a-2cde-44c0-9350-3aeab9f7091b 2025-09-12 Warnings Exact identifier application number: M020 Dolce and Gabbana Get Your Healthy Glowy Skin Bergamot Glow Primer Blueberry Nutri Tint ZINC OXIDE Dolce & Gabbana Beauty S.R.L e375412e-8685-49a2-b1b0-00ab114e14b7 2025-09-12 Warnings Exact identifier application number: M020 Beach Club Mineral Sunscreen ZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATE R & R Lotion, Inc d9aae241-229e-4123-abe9-99f74f5ab0b3 2025-09-12 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