FDA.reportPublic FDA data

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
IngredientStrength
OCTINOXATE7.4 g/100g
HOMOSALATE6.2 g/100g
OCTISALATE5 g/100g
OXYBENZONE3.1 g/100g
AVOBENZONE1.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
95OOS7VE0YInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
65c28ed6-649d-41d9-b214-aab6ccb02dd5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72104-082-72Introstem Vitiscell Facial Shield60 g in 1 JARCREAM602
72104-082-72Introstem Vitiscell Facial Shield1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72104-082INTROSTEM VITISCELL FACIAL SHIELD (OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE) CREAM [LIONESSE USA, INC.]1Current NDC, 2 package rows20240302_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 243 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tender Moments Baby Sunscreen Broad Spectrum SPF 50 Water Resistant (40 minutes)AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEDistribuidora Comercial Jafra, S.A. de C.V.c3bacceb-63a8-098c-e053-2995a90acd642025-01-02WarningsExact identifier
application number: M020
Sheer Daily Wear Face Protection Mineral Based Sunscreen SPF 16ZINC OXIDEREJUVA MINERALS INC3d83c220-1801-4193-b6a8-c777f412c1732025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SaddleZINC OXIDEEVER FAME PTE. LTD.2abf69c5-07d7-252d-e063-6394a90a292b2025-01-02WarningsExact identifier
application number: M020
Sheglam Dew and Done Skin Tint with SPF 20 SandZINC OXIDEEVER FAME PTE. LTD.2abf7869-4418-7738-e063-6394a90ae89d2025-01-02WarningsExact identifier
application number: M020
Good Weather Skin The One Daily Sun SPF 30ZINC OXIDEGood Weather Inc.2ac30544-5ece-18ed-e063-6394a90a6a0d2025-01-02WarningsExact identifier
application number: M020
Exel Clarifying Line Daily Fluid Sun Shield white color Broad Spectrum SPF 60 plusOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.283c2780-5ad5-38f1-e063-6294a90ac3362025-01-01WarningsExact identifier
application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEBiocosmetica Exel Argentina SRL2aabf782-65f9-e894-e063-6394a90a1ea32025-01-01WarningsExact identifier
application number: M020
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEBiocosmetica Exel Argentina SRL2aad5b97-e64b-c678-e063-6294a90aa8c62025-01-01WarningsExact identifier
application number: M020
TIBENA ALWAYS REAL SUN BLOCK UV SPF 45AVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENEKONAD CO LTD2aafbd33-710a-201e-e063-6294a90ab1bb2025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC SPF 50 Apricot Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30ac897-3a30-7bba-e053-2995a90ac3422025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Apricot BeigeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30b0588-b0f4-39a8-e053-2a95a90abb352025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC SPF 50 Natural Beige Oil-FreeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30aeaa6-3423-401c-e053-2a95a90a8fe92025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Cushion CC Total Cover SPF 50 Natural BeigeENSULIZOLE, TITANIUM DIOXIDEfmg Co.Ltdd30afd94-8bcd-01bc-e053-2a95a90afb492025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Natural Sun Oil-Free Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltdd30b156a-b9b1-499b-e053-2a95a90ada6a2025-01-01WarningsExact identifier
application number: M020
THEFACESHOP Natural Sun Long Lasting Sunscreen Broad Spectrum SPF 50ENSULIZOLE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDEfmg Co.Ltdd30b183d-a54d-752c-e053-2a95a90a24fc2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltdd6dcdb08-3407-90e1-e053-2a95a90a83bf2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE ACTIVE FACE AND BODY PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltdd6de8135-3c70-2036-e053-2995a90a040b2025-01-01WarningsExact identifier
application number: M020
ISA KNOX LXNEW PLATINUM SCULPTING DAY BROAD SPECTRUM SPF 30 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltdd6deadbd-524f-7506-e053-2a95a90a0a1b2025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY MINERAL FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENZINC OXIDEfmg Co.Ltd02e61a43-3021-edc1-e063-6294a90ad4b62025-01-01WarningsExact identifier
application number: M020
ISA KNOX ANEW SOLAIRE EVERYDAY FACE PROTECTION BROAD SPECTRUM SPF 50 SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEfmg Co.Ltd02e64868-d545-4af7-e063-6394a90aa7c72025-01-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72104-082-72721040082721 JAR in 1 CARTON (72104-082-72) / 60 g in 1 JAR1 jar2023-10-01NoNoCurrent