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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68828-003	68828-003-02	D	Discontinued by firm		2026-10-21

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G63QQF2NOX	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
865057ce-f617-4232-a60e-e23c120b0a73	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 99 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DR.JART EVERY SUN DAY MINERAL SUN SCREEN	TITANIUM DIOXIDE, ZINC OXIDE	Have & Be Co., Ltd.	f06c31b4-da5f-6495-e053-2995a90ae67c	2025-12-31	Warnings	Exact identifier application number: M020
ALMOST powder MAKEUP BROAD SPECTRUM SPF 18	OCTINOXATE AND TITANIUM DIOXIDE	CLINIQUE LABORATORIES LLC	402add6d-a81e-4c9e-aee1-4abeb480894f	2025-12-31	Warnings	Exact identifier application number: M020
RED GECKO BROAD SPECTRUM SPF 30 SUNSCREEN	ZINC OXIDE	Formula 7venz L.L.C.	e8e350e7-9225-4802-89a6-66e45ebc442d	2025-12-31	Warnings	Exact identifier application number: M020
Kinfield Daily Dew Sea Kelp Moisturizer Sunscreen Broad Spectrum SPF 35	KINFIELD DAILY DEW SEA KELP MOISTURIZER SUNSCREEN LOTION BROAD SPECTRUM SPF 35	Kinfield, Inc.	0710db9f-fe91-4b98-a337-5fde33d98a9d	2025-12-30	Warnings	Exact identifier application number: M020
Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35	KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35	Kinfield, Inc.	1030c5a4-3067-48e6-a21c-0d327ef434d0	2025-12-30	Warnings	Exact identifier application number: M020
Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35	KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35	Kinfield, Inc.	612c5730-c3b4-486e-8ce9-8a861f676fa8	2025-12-30	Warnings	Exact identifier application number: M020
Kinfield Liplock SPF 15 Lip Balm Broad Spectrum Sunscreen	KINFIELD LIPLOCK SUNSCREEN	Kinfield, Inc.	477aa1a2-c893-4750-84da-e5afe7ccd45b	2025-12-30	Warnings	Exact identifier application number: M020
Kinfield Sunglow Luminizing Facial Sunscreen Broad Spectrum SPF 35	KINFIELD SUNGLOW LUMINIZING FACIAL SUNSCREEN BROAD SPECTRUM SPF 35	Kinfield, Inc.	cbdfd0ae-514b-4b53-98ad-4270163bd0df	2025-12-30	Warnings	Exact identifier application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Fair	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	472f4f34-99bc-2ff6-e063-6294a90a33c9	2025-12-30	Warnings	Exact identifier application number: M020
EVEN BETTER CLINICAL VITAMIN MAKEUP BROAD SPECTRUM SPF 45	ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDE	CLINIQUE LABORATORIES LLC	2397aca5-bf0a-619d-e063-6394a90a7ab9	2025-12-30	Warnings	Exact identifier application number: M020
Resource Essentials Sun Protection Mineral SPF 30	14% ZINC OXIDE	Skinresource.md, L.L.C.	45b486cf-28ee-6392-e063-6394a90affb0	2025-12-30	Warnings	Exact identifier application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Light Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47313277-8884-70b5-e063-6394a90a5fca	2025-12-30	Warnings	Exact identifier application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47320858-0aea-6ee9-e063-6294a90a9fa9	2025-12-30	Warnings	Exact identifier application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Light Warm	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47325530-b097-db9a-e063-6294a90a335d	2025-12-30	Warnings	Exact identifier application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Tan	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47328eb4-8ad7-28b5-e063-6294a90a20b1	2025-12-30	Warnings	Exact identifier application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Tan Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4732bbec-d9f9-1639-e063-6394a90aff82	2025-12-30	Warnings	Exact identifier application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4732ecd0-5261-7f11-e063-6394a90a26f3	2025-12-30	Warnings	Exact identifier application number: M020
ScalpProtectionSpray	SCALP PROTECTION SPRAY	Naturich Labs	c227ff3a-bbbb-5cc5-e053-2a95a90a8e32	2025-12-30	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	0918fdd3-cffb-78e9-e063-6394a90ad5c7	2025-12-30	Warnings	Exact identifier application number: M020
SLMD	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Skin PS Brands	1aa36c01-21b5-f06e-e063-6294a90a608f	2025-12-30	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Spa Niacinamide And Vitamin E Hand Cream Broad Spectrum SPF 15	Distribuidora Comercial Jafra, S.A. de C.V. \| Jafra Cosmetics International Inc	2025-11-05	HUMAN OTC DRUG LABEL	7