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 221 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sun Shades Lip Balm Cranberry Tangerine AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3% Melaleuca Inc. f39606be-19c8-58d1-e053-2a95a90a908f 2025-03-20 Warnings Exact identifier application number: M020 Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15) HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC aa937596-2378-469f-a0e1-9700044e83b3 2025-03-20 Warnings Exact identifier application number: M020 Obagi Medical Way to Glow Kit HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC f6f6e219-4ef6-be3b-e053-6294a90a660d 2025-03-20 Warnings Exact identifier application number: M020 Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20) HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC e8d19915-8996-42df-a47b-2ce00d2bbe68 2025-03-20 Warnings Exact identifier application number: M020 SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42 ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE SHISEIDO AMERICAS CORPORATION 21bde283-a554-45c8-8733-2a8adeff41b1 2025-03-20 Warnings Exact identifier application number: M020 SHISEIDO ULTIMATE SUN PROTECTOR OCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONE SHISEIDO AMERICAS CORPORATION 7a98171f-bf21-40d4-bc78-883aa0b0c438 2025-03-20 Warnings Exact identifier application number: M020 Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 5e2d7c94-d70a-47e4-9a4b-5953fe38ede2 2025-03-19 Warnings Exact identifier application number: M020 Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15 OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 50206f9e-2dd5-494f-9eed-f7d7ea6efda9 2025-03-18 Warnings Exact identifier application number: M020 Hello Sun Silky Glow Broad Spectrum SPF40 ZINC OXIDE The Creme Shop 30a4280b-4a9f-4c18-e063-6394a90a85e6 2025-03-18 Warnings Exact identifier application number: M020 Vertra Invisible Sunscreen Face Stick Broad Spectrum SPF 45 ZINC OXIDE Eai-jr 286, Inc 30a5ec14-63d7-e678-e063-6294a90abb57 2025-03-18 Warnings Exact identifier application number: M020 EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE Extra Shade, LLC d197dfe3-c754-4a3d-9edd-335f3fce105c 2025-03-18 Warnings Exact identifier application number: M020 Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE L'Oreal USA Products Inc c88e44da-0b0e-4744-8b4b-4d9d418f29d7 2025-03-18 Warnings Exact identifier application number: M020 MDP UV BIO SUNSCREEN ZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE SKINIDEA CO., LTD 3087771e-2ab8-2198-e063-6294a90a37d4 2025-03-17 Warnings Exact identifier application number: M020 belif Dew guard - milky sun serum Broad Spectrum SPF 40 sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LG H&H CO., LTD. 2b38da59-b83e-4285-e063-6294a90ac6a7 2025-03-17 Warnings Exact identifier application number: M020 SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN HOMOSALATE, OCTISALATE, AND ZINC OXIDE Obagi Cosmeceuticals LLC 263ef8e8-e0c4-42e6-bb26-7581a437b35a 2025-03-14 Warnings Exact identifier application number: M020 Impact Melanoma SPF 30 ZINC OXIDE RENU LABORATORIES, LLC f953302e-f712-129a-e053-6294a90ab9a8 2025-03-13 Warnings Exact identifier application number: M020 Vertra Ehukai Beige Sunscreen Face Stick Broad Spectrum SPF 38 TITANIUM DIOXIDE Eai-jr 286, Inc 303d5d5a-4c7a-1e23-e063-6294a90a0e58 2025-03-13 Warnings Exact identifier application number: M020 belif Dew guard - daily mineral sunscreen Broad Spectrum SPF 50 ZINC OXIDE LG H&H CO., LTD. 2b4c363b-f767-7901-e063-6394a90adba5 2025-03-13 Warnings Exact identifier application number: M020 Zinc Oxide MINERAL SUNSHIELD UNIVERSAL TINT BROAD SPECTRUM SPF 30 SUNSCREEN Vege Labs LLC 303e84e1-3bea-ea6f-e063-6294a90aeaa7 2025-03-13 Warnings Exact identifier application number: M020 MURASAKI BEAUTY Silicence Scar Gel SPF 30 ZINC OXIDE, ETHYLHEXYL METHOXYCINNAMATE Haikou Pucao Trading Co.,Ltd 303f7dd6-aef2-30ce-e063-6394a90ac00f 2025-03-13 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