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 228 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30 TITANIUM DIOXIDE AND ZINC OXIDE DERM ASSO. MID OHIO 2d04bc5d-6f11-4f56-e063-6294a90ae755 2025-01-31 Warnings Exact identifier application number: M020 TiZO Mineral Sun Defense SPF 50 TITANIUM DIOXIDE, ZINC OXIDE Fallien Cosmeceuticals Ltd. 2d0766a1-4091-e84a-e063-6394a90a004a 2025-01-31 Warnings Exact identifier application number: M020 Hello Sunday The Shimmer One Mineral Glow SPF 45 ZINC OXIDE Kao USA Inc. 0c935521-4e8b-0605-e063-6394a90a0bbc 2025-01-31 Warnings Exact identifier application number: M020 Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kao USA Inc. 0c7ce5b9-5ab4-d845-e063-6394a90afa76 2025-01-31 Warnings Exact identifier application number: M020 Hello Sunday The Mineral One Lightweight Serum SPF 50 ZINC OXIDE Kao USA Inc. 0c91894f-a40e-73e9-e063-6394a90ab807 2025-01-31 Warnings Exact identifier application number: M020 Hello Sunday The One Thats a Serum Hydrating Serum SPF 45 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kao USA Inc. 0c913096-c000-4336-e063-6394a90a560c 2025-01-31 Warnings Exact identifier application number: M020 Hello Sunday Bestseller Daily SPF Duo AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kao USA Inc. 26cf264b-f68d-5691-e063-6394a90a8ab4 2025-01-31 Warnings Exact identifier application number: M020 TiZO Ultra Zinc SPF 40 (Tinted) ZINC OXIDE Fallien Cosmeceuticals, LTD 2d0856cf-d3da-5a77-e063-6294a90ad5b4 2025-01-31 Warnings Exact identifier application number: M020 FRE PROTECT BODY Ultra-Light Gel Cream SPF 50 ZINC OXIDE Peer Pharm Ltd. 2cd83c55-851c-089e-e063-6294a90ad6bc 2025-01-30 Warnings Exact identifier application number: M020 FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50 ZINC OXIDE Peer Pharm Ltd. 2cd958a3-bad6-725e-e063-6294a90a8578 2025-01-30 Warnings Exact identifier application number: M020 FRE PLUMP ME PEPTIDE LIP TINT CASSIS SPF 30 ZINC OXIDE Peer Pharm Ltd. 2cd77d62-77df-f3a9-e063-6394a90ad57d 2025-01-30 Warnings Exact identifier application number: M020 FRE PLUMP ME PEPTIDE LIP TINT PAMPELONNE SPF 30 ZINC OXIDE Peer Pharm Ltd. 2caf3b6b-3a05-b24a-e063-6394a90a4799 2025-01-30 Warnings Exact identifier application number: M020 Jil Goorman Skincare Sun Guard SPF 30 AVOBENZONE, OCTISALATE, OCTOCRYLENE SAN DIEGO NATURAL SOAP COMPANY 9a088bed-3b85-4bf5-923b-4c99eb904a8d 2025-01-30 Warnings Exact identifier application number: M020 FRE PLUMP ME PEPTIDE LIP TINT MONACO SPF 30 ZINC OXIDE Peer Pharm Ltd. 2baf0278-7e13-4db0-e063-6294a90ae9de 2025-01-30 Warnings Exact identifier application number: M020 Babo Botanicals Sensitive Baby Mineral Sunscreen SPF50 ZINC OXIDE Babo Botanicals, Inc. 08a175ae-2307-ef8d-e063-6394a90ad234 2025-01-30 Warnings Exact identifier application number: M020 Babo Botanicals Super Shield Mineral Sunscreen SPF50 ZINC OXIDE Babo Botanicals, Inc 08b7bcfd-0c7c-a14f-e063-6294a90a7797 2025-01-30 Warnings Exact identifier application number: M020 Salt and Stone Sunscreen Lip Balm SPF 30 ZINC OXIDE Salt and Stone LLC b555aa10-1547-63cc-e053-2995a90ad20d 2025-01-30 Warnings Exact identifier application number: M020 COVER plus CORRECT/TINTED MOISTURIZER CC CRM FAIR OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE Bluemercury 5c590aed-d2f2-4478-8919-37c848752b42 2025-01-29 Warnings Exact identifier application number: M020 LiProtect SPF 35 ZINC OXIDE, TITANIUM DIOXIDE Science of Skincare 0d0a2657-4098-3c60-e063-6294a90acabb 2025-01-29 Warnings Exact identifier application number: M020 Perfect Sunscreen Tinted Mineral SPF50 ZINC OXIDE Bluemercury, Inc. 4c978154-679f-472a-95ab-56878c5c70cd 2025-01-29 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