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 325 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spit and Polish Mineral Lip Balm Broad Spectrum Lip Protectant SPF 30ZINC OXIDENaturally Uncommon, LLCaf882b7e-c64f-0de6-e053-2995a90a7ca02023-11-09WarningsExact identifier
application number: M020
EltaMD UV AOX MistZINC OXIDE SUNSCREENCP Skin Health Group, Inc1062efb1-a638-4323-88f8-f2f98a5b996e2023-11-09WarningsExact identifier
application number: M020
EltaMD UV ActiveZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.2c523aa0-7c34-4fc2-98a0-f2fdfe6d2cd22023-11-09WarningsExact identifier
application number: M020
Physical Sunscreen SPF50 80 min WR 159-100TITANIUM DIOXIDE, TITANIUM DIOXIDE SUNSCREENSwiss-American CDMO, LLC0cca7b65-e24a-429c-b157-5f4e343424ab2023-11-09WarningsExact identifier
application number: M020
Private Label Sunscreen SPF35 40min WR RE126-202HOMOSALATE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC254fa69f-2413-47e8-bc9b-5b7b0b59a5c82023-11-09WarningsExact identifier
application number: M020
PLANTSCRIPTION SPF 25 POWER ANTI-AGING oil FREE BROAD SPECTRUMAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEORIGINS NATURAL RESOURCES INC.91c14980-ba63-4705-a465-581fe11d0a982023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0NOCTISALATE, TITANIUM DIOXIDEGuerlaina20dc51a-1f6c-4a6d-97f6-2f048e0689a02023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5COCTISALATE, TITANIUM DIOXIDEGuerlaina6c8b20f-6377-443b-a89b-8b5d40c65ad82023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5NOCTISALATE, TITANIUM DIOXIDEGuerlainb6591b2e-9e55-4f25-958c-f36f1ef857492023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1.5NOCTISALATE, TITANIUM DIOXIDEGuerlain6e2ae7cb-c390-4996-95e8-ae8fadefa8bd2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1NOCTISALATE, TITANIUM DIOXIDEGuerlaina143c8cb-185c-4fd8-a901-3c0d9ffb82902023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1COCTISALATE, TITANIUM DIOXIDEGuerlain3d6e438d-9ea4-4253-9153-748d3c9742652023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2NOCTISALATE, TITANIUM DIOXIDEGuerlain173aeaab-a286-48ed-9033-10b13f547bbd2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3.5NOCTISALATE, TITANIUM DIOXIDEGuerlaind877575a-25f3-49bd-b403-ecf6a1eb483a2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 5NOCTISALATE, TITANIUM DIOXIDEGuerlain24e1e576-9edd-45aa-a883-2a2d18a1cb5e2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 6NOCTISALATE, TITANIUM DIOXIDEGuerlaina8fffe38-5f90-4078-b553-30036659a2ee2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 7NOCTISALATE, TITANIUM DIOXIDEGuerlainbfa2b2be-958c-439f-b363-2623df2b85012023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 3NOCTISALATE, TITANIUM DIOXIDEGuerlain15f73322-0b27-4412-b368-84bc768f55e82023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 2WOCTISALATE, TITANIUM DIOXIDEGuerlain51392fe6-fbbb-4ea9-a7aa-98e1711eaa5d2023-11-08WarningsExact identifier
application number: M020
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 4NOCTISALATE, TITANIUM DIOXIDEGuerlainb70b8ffc-091a-4969-86a7-6c3e1b9b9d742023-11-08WarningsExact 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