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 273 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hawaiian TropicAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC77cdd346-d273-ed66-e053-2991aa0ae31d2024-10-31WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC767accea-c5b2-32dc-e053-2991aa0a33382024-10-31WarningsExact identifier
application number: M020
ZO Skin Health Sheer Fluid Broad-Spectrum Sunscreen SPF 50ZINC OXIDEZO Skin Health, Inc.f218c158-19aa-ab90-e053-2a95a90aaef32024-10-31WarningsExact identifier
application number: M020
Banana BoatZINC OXIDEEdgewell Personal Care Brands LLC1ce728be-966e-b662-e063-6394a90a0ba82024-10-30WarningsExact identifier
application number: M020
RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENECOSMAX USA, INC.2596a17e-4042-3544-e063-6294a90aa4c92024-10-29WarningsExact identifier
application number: M020
SunbloczZINC OXIDEOlen Skin Care Corporation36fec1f1-5e8b-5764-e054-00144ff8d46c2024-10-29WarningsExact identifier
application number: M020
Sunblocz Baby and KidsZINC OXIDEOlen Skin Care Corporation35cbb9d5-639c-207a-e054-00144ff88e882024-10-29WarningsExact identifier
application number: M020
ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes)AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEZO Skin Health, Inc.fd7d40fe-178a-e1b1-e053-6294a90a29a12024-10-29WarningsExact identifier
application number: M020
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZO Skin Health, Inc.9a4f5be1-da04-48b9-897a-57f4a3d9d1ec2024-10-29WarningsExact identifier
application number: M020
TiZO Ultra Zinc SPF 40 (Non-Tinted)ZINC OXIDEFallien Cosmeceuticals, LTDe4a06973-21bb-4eda-9b74-fc23bee141ab2024-10-29WarningsExact identifier
application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD36efd48b-910e-4b61-9519-a6d5c7e9a7c32024-10-29WarningsExact identifier
application number: M020
ZO Skin Health Broad-Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health, Inc.d817f80b-a998-b67e-e053-2995a90a19712024-10-29WarningsExact identifier
application number: M020
SPF 15 Coconut Lip BalmZINC OXIDENaples Soap Company, Inc.25a7510f-5ef3-9920-e063-6394a90a20792024-10-29WarningsExact identifier
application number: M020
Defense Total High Protection SPF 50 No Color Daily Non-Greasy Face ProtectionHOMOSALATE, OCTOCRYLENE, AVOBENZONEBel Star S.A. (Colombia)a7d69691-cecc-798e-e053-2a95a90a995f2024-10-28WarningsExact identifier
application number: M020
LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-FOCTINOXATE, ZINC OXIDEBel Star S.A.eea17271-e8c8-ab21-e053-2995a90a2fcc2024-10-28WarningsExact identifier
application number: M020
LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENEBEL STAR SAfd90ffc6-a1e1-e02e-e053-6294a90a4e7c2024-10-28WarningsExact identifier
application number: M020
LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-NOCTINOXATE, ZINC OXIDEBEL STAR S.A.0b782198-58e7-5343-e063-6294a90a37132024-10-28WarningsExact identifier
application number: M020
FHF Elevated Shade 100% Mineral SunscreenSUNSCREENOwen Biosciences Incdabd3b95-01d3-014c-e053-2a95a90a0fec2024-10-28WarningsExact identifier
application number: M020
RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBAY BELLE LABS259653e7-dfe0-44a2-e063-6294a90a416d2024-10-28WarningsExact identifier
application number: M020
Banana BoatAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC8a21acbe-2f3d-cf78-e053-2a95a90a77f62024-10-27WarningsExact 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