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 211 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesb8f08778-7e5e-4341-9a24-1ce57c6525c72025-06-05WarningsExact identifier
application number: M020
Quick Dry Body Broad Spectrum SPF40 Sunscreen UVA-UVB Sunscreen with SolSci-XAVOBENZONE, OCTISALATE, AND OCTOCRYLENEMDSolarSciences812caa99-1e1e-4ab8-9f9a-fb3384c684dd2025-06-05WarningsExact identifier
application number: M020
MD Daily Perfecting Moisturizer SPF 30. SPF 30 Broad Spectrum Sunscreen UVA-UVBAVOBENZONE, OCTOCRYLENE, AND OCTISALATEMDSolarSciencesba918886-d277-487a-be3b-bbe3e24343ad2025-06-05WarningsExact identifier
application number: M020
Gleam plus Glow SPF 50. SPF 50 Broad Spectrum Sunscreen UVA-UVB Sheer Glow TintAVOBENZONE, OCTISALATE, AND OCTOCRYLENEMDSolarSciences3e392af6-1401-4a2f-9ba4-e43f0fd0fca12025-06-05WarningsExact identifier
application number: M020
Tint plus Tone SPF 50. SPF 50 Broad Spectrum Sunscreen Sheer Tinted MoisturizerAVOBENZONE, OCTISALATE, AND OCTOCRYLENEMDSolarSciences51bd8962-e85a-4964-9337-2ded6b7d8ac82025-06-05WarningsExact identifier
application number: M020
Hydrating Sheer Lip Balm SPF 30 -Crystal Broad Spectrum SPF 30 UVA-UVB SunscreenAVOBENZONE, OCTISALATE, AND HOMOSALATEMDSolarSciences0f23441c-2399-4a72-9f0a-420d25db78af2025-06-05WarningsExact identifier
application number: M020
Vacation Classic Whip SPF 30 Broad Spectrum SPF 30HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEVacation Inc.36da165b-bc68-24ff-e063-6294a90a304f2025-06-05WarningsExact identifier
application number: M020
Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDENemah, Inc.36da2d94-fa90-b145-e063-6394a90a58542025-06-05WarningsExact identifier
application number: M020
Mineral KidStick SPF 40 Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences4c7f0257-fa12-40d6-9516-824b0e3a182c2025-06-05WarningsExact identifier
application number: M020
Mineral KidCreme SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences9ec56c68-6fea-444b-aeed-0b5d60c42e752025-06-05WarningsExact identifier
application number: M020
Kidspray Broad Spectrum Sunscreen SPF 40AVOBENZONE, OCTISALATE, AND OCTOCRYLENEMDSolarSciences36df811b-35d2-261d-e063-6394a90aa91e2025-06-05WarningsExact identifier
application number: M020
5-IN-1 TINTED FACE SUNSCREEN - FAIRZINC OXIDESynchronicity Spa, Inc. DBA Suntegrityc0892856-cd12-4c1f-8420-866dbd0f89072025-06-04WarningsExact identifier
application number: M020
Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCfbf8be03-93e2-4d7e-e053-6294a90a4fd52025-06-04WarningsExact identifier
application number: M020
EltaMD UV Clear SPF46ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.60438ec5-0b1f-45fd-8ce4-debfdbdc67212025-06-04WarningsExact identifier
application number: M020
LikePro Skincare Sport Day UV Face Sunscreen SPF 50OCTOCRYLENE, ZINC OXIDELIKE PRO OPTIMAL SKINCARE LLCb00d0efe-bf22-43a6-ba24-3d5b6ee9c5e12025-06-03WarningsExact identifier
application number: M020
LikePro Skincare Sport Day UV Face and Body Sunscreen SPF 50ZINC OXIDELIKE PRO OPTIMAL SKINCARE LLC2ea86aa8-2f28-40bb-9318-fec188f660102025-06-03WarningsExact identifier
application number: M020
LikePro Skincare Sport Day UV Face and Body Sunscreen SPF 50ZINC OXIDELIKE PRO OPTIMAL SKINCARE LLCb59a3b67-0e44-426d-9379-0ca31628937a2025-06-03WarningsExact identifier
application number: M020
EthoSun EthoSport Stick Broad Spectrum SPF 40ZINC OXIDEEthoSun, Inc35372859-8f40-5eb0-e063-6294a90a6a002025-06-03WarningsExact identifier
application number: M020
EthoSun Daily Mineral Sunscreen Broad Spectrum SPF 45ZINC OXIDEEthoSun, Incd7d2bca6-5000-4cb9-b004-b1ae286f60352025-06-03WarningsExact identifier
application number: M020
Age Defense for Eyes 5 in 1ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.48d5343a-1068-4c64-a275-c180026d69472025-06-03WarningsExact 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