Introstem Vitiscell Facial Shield

Product NDC: 72104-082
11-digit product format: 721040082
Labeler code: 72104
Product ID: 72104-082_ea6cba08-1cdf-464f-8962-7dc10ff8a4a9
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate, Homosalate, Octisalate, Oxybenzone and Avobenzone
Dosage form: CREAM
Route: TOPICAL
Labeler: Innovation Brands Inc.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-10-01
Substance: OCTINOXATE; HOMOSALATE; OCTISALATE; OXYBENZONE; AVOBENZONE
Active strength: 7.4; 6.2; 5; 3.1; 1.5 g/100g; g/100g; g/100g; g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Introstem Vitiscell Facial Shield
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	7.4 g/100g
HOMOSALATE	6.2 g/100g
OCTISALATE	5 g/100g
OXYBENZONE	3.1 g/100g
AVOBENZONE	1.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
95OOS7VE0Y	Internal UNII lookup
G63QQF2NOX	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
65c28ed6-649d-41d9-b214-aab6ccb02dd5	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72104-082-72	Introstem Vitiscell Facial Shield	60 g in 1 JAR	CREAM	60		2
72104-082-72	Introstem Vitiscell Facial Shield	1 in 1 CARTON	CREAM	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72104-082	INTROSTEM VITISCELL FACIAL SHIELD (OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE) CREAM [LIONESSE USA, INC.]	1	Current NDC, 2 package rows	20240302_65c28ed6-649d-41d9-b214-aab6ccb02dd5.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 290 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clarity Rx Pucker Power lip plumper SPF 30	HOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE	Topiderm, Inc.	92504982-fe0e-404d-b7cf-f6b340b89802	2024-07-31	Warnings	Exact identifier application number: M020
Essential Sheer SPF 50	ZINC OXIDE TITANIUM DIOXIDE	Topiderm, Inc.	2132dc18-85ee-4449-86d2-d9f698f286c6	2024-07-31	Warnings	Exact identifier application number: M020
Proceuticals Private Label by TiZO tinted foaming mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, Ltd	1e78109f-4d2e-2705-e063-6294a90a5ad3	2024-07-30	Warnings	Exact identifier application number: M020
Replenix Sheer SPF 50	ZINC OXIDE TITANIUM DIOXIDE	Topiderm, Inc.	37d1f454-3bc9-4ce5-863c-0d4f6fa18fb4	2024-07-29	Warnings	Exact identifier application number: M020
Dr Pawpaw MultiPurpose Lip Balm with natural PawPaw and SPF 30	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE, OCTISALATE	Dr Pawpaw Limited	f2628e3e-9eb0-49cb-91a6-d15c48cb8a19	2024-07-25	Warnings	Exact identifier application number: M020
Thinksport Daily Face SPF 50	ZINC OXIDE	thinkOperations,LLC	b2422785-bd35-4248-a68f-fb4b1492a4cd	2024-07-24	Warnings	Exact identifier application number: M020
Thinkbaby Clear Zinc SPF 30	ZINC OXIDE	thinkOperations,LLC	7cd9c971-5556-42dc-af7b-3a88221b8c94	2024-07-24	Warnings	Exact identifier application number: M020
ISNTREE ONION NEWPAIR SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	ISNTREE Inc.	0f072099-d57d-4dc4-e063-6394a90ab438	2024-07-23	Warnings	Exact identifier application number: M020
ISNTREE ONION NEWPAIR SUNSCREEN	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	ISNTREE Inc.	14b11b42-d1fe-572f-e063-6394a90a9eec	2024-07-23	Warnings	Exact identifier application number: M020
Proceuticals Private Label by TiZO tinted mineral sunscreen 20% zinc oxide	ZINC OXIDE	Fallien Cosmeceuticals, Ltd	1dda8259-4121-3c76-e063-6394a90af189	2024-07-22	Warnings	Exact identifier application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Sport SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Eco Lips. Inc.	e64c8644-7af4-7b7f-e053-2995a90af711	2024-07-22	Warnings	Exact identifier application number: M020
Thinksport SPF 30	ZINC OXIDE	thinkOperations,LLC	2cecda56-4860-4d35-abc2-2bb9bdf35eae	2024-07-19	Warnings	Exact identifier application number: M020
CVS Health SPORT SPF 30	AVOBENZONE HOMOSALATE OCTOCRYLENE	CVS PHARMACY	f0e8c724-b377-5dc0-e053-2995a90a0d54	2024-07-18	Warnings	Exact identifier application number: M020
EQUATE Sunscreen SPORT Broad Spectrum SPF 30	AVOBENZONE HOMOSALATE OCTOCRYLENE	WAL-MART STORES INC	4d819fd3-de12-4394-82f4-a48faf0b7092	2024-07-18	Warnings	Exact identifier application number: M020
Big Lots Soundbody SPF 30 Ultra Sport Sunscreen	AVOBENZONE HOMOSALATE OCTOCRYLENE	BIG LOTS STORES, INC.	f0e82a9f-17ac-b1c5-e053-2995a90ae07a	2024-07-18	Warnings	Exact identifier application number: M020
Equaline SPORT Sunscreen SPF 30	AVOBENZONE HOMOSALATE OCTOCRYLENE	United Natural Foods, Inc. dba UNFI	f0e8dfd4-a77c-6384-e053-2a95a90a1e4a	2024-07-18	Warnings	Exact identifier application number: M020
TopCare Everyday SPORT Sun Broad Spectrum SPF 30	AVOBENZONE HOMOSALATE OCTOCRYLENE	TOPCO ASSOCIATES LLC	f0e93aa8-1b09-1312-e053-2a95a90a7934	2024-07-18	Warnings	Exact identifier application number: M020
Safeway Signature Sport Sunscreen SPF 30	AVOBENZONE HOMOSALATE OCTOCRYLENE	Safeway, Inc.	f557a3e2-e415-1b65-e053-2995a90a987a	2024-07-18	Warnings	Exact identifier application number: M020
Target Up and Up Sunscreen Sport Broad Spectrum SPF 30	AVOBENZONE HOMOSALATE OCTOCRYLENE	TARGET CORPORATION	bad60bc1-cf78-7a33-e053-2995a90afdc3	2024-07-18	Warnings	Exact identifier application number: M020
Scar Gel SPF 35	ZINC OXIDE	derma e	8cd263aa-a54b-4c55-b3e2-6f6763987d4a	2024-07-17	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72104-082-72	72104008272	1 JAR in 1 CARTON (72104-082-72) / 60 g in 1 JAR	1 jar	2023-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Introstem ® VitisCell Facial Shield Cream	Innovation Brands Inc.	2025-07-01	HUMAN OTC DRUG LABEL	2