FDA.reportPublic FDA data

Introstem PrismaStem Face Shield Cream

Product NDC
72104-042
11-digit product format
721040042
Labeler code
72104
Product ID
72104-042_dd91374a-e3fc-42f1-a660-86b32a0cc8b8
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
2025-01-13
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 PrismaStem Face Shield Cream
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
dd91374a-e3fc-42f1-a660-86b32a0cc8b8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72104-042-01Introstem PrismaStem Face Shield Cream60 g in 1 JARCREAM601
72104-042-01Introstem PrismaStem Face Shield Cream1 in 1 CARTONCREAM11

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 203 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Basin Juicy Watermelon SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8a093b-cc9c-26fc-e063-6394a90a20282025-07-22WarningsExact identifier
application number: M020
Basin Coconut SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8a87d6-ef86-60c2-e063-6394a90a07062025-07-22WarningsExact identifier
application number: M020
Basin Eucalyptus Mint SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8b773c-f456-836a-e063-6294a90a0d462025-07-22WarningsExact identifier
application number: M020
Basin Strawberry SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8bc90d-350f-98c8-e063-6294a90abd9c2025-07-22WarningsExact identifier
application number: M020
Basin Peach Apricot SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a8bd5d8-1c4c-0407-e063-6394a90a138f2025-07-22WarningsExact identifier
application number: M020
CLEAR GLOW RADIANT SUN SERUM SPF50AVOBENZONE 15MG/G, HOMOSALATE 5MG/G, OCTOCRYLENE 25MG/G, (SUNSCREEN)NAKED SUNDAYS PTY LTDd748e291-3a29-663c-e053-2995a90a8d922025-07-22WarningsExact identifier
application number: M020
La Defense Broad Spectrum SPF 30 Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDELuzern Laboratories, Inc3f00befa-415d-415d-89e1-6ba8770ba51e2025-07-21WarningsExact identifier
application number: M020
PREDIRE PARIS skin shield protector mineral defense creamPREDIRE PARIS SKIN SHIELD PROTECTOR MINERAL DEFENSE CREAMGuangzhou Fantesy Biotechnology Co.,Ltd3a7c1345-532f-b38f-e063-6394a90a52452025-07-21WarningsExact identifier
application number: M020
Medicated Peppermint Lip BalmDIMETHICONE, UNSPECIFIED, OCTINOXATE, AND OCTISALATEBlistex Inc5d48a6fa-ddce-47c3-9b09-1f3abb6950172025-07-18WarningsExact identifier
application number: M020
ICD Moisture Layer SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEICD Moisture Layer Sunscreen3a2a74f2-9fed-808f-e063-6294a90a410c2025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 2ZINC OXIDEG2G Ventures, PBC3a35c95b-10eb-689f-e063-6394a90ae1d42025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 3ZINC OXIDEG2G Ventures, PBC3a35bbb2-a1eb-346b-e063-6294a90a90782025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 4ZINC OXIDEG2G Ventures, PBC3a35f23b-3732-db3c-e063-6294a90ae00c2025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 5ZINC OXIDEG2G Ventures, PBC3a35fd79-f4d3-5ccf-e063-6294a90a97982025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 6ZINC OXIDEG2G Ventures, PBC3a360053-5863-95fe-e063-6394a90a45c52025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 8ZINC OXIDEG2G Ventures, PBC3a362e05-3a1e-8059-e063-6294a90ad5252025-07-18WarningsExact identifier
application number: M020
Counter Beauty Dew Skin Tinted Moisturizer No. 7ZINC OXIDEG2G Ventures, PBC3a3621c2-709a-82fd-e063-6294a90a7a7e2025-07-18WarningsExact identifier
application number: M020
Basin Pina Colada SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc3a39ac31-85c9-5e04-e063-6394a90aa5372025-07-18WarningsExact identifier
application number: M020
Basin American Pink Lemonade SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3afeda-f235-eac2-e063-6294a90a5a932025-07-18WarningsExact identifier
application number: M020
Basin Chinese Mandarin SPF 15 Broad Spectrum Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENERetail Concepts of Minnesota, Inc.3a3b5f56-aa36-01c7-e063-6294a90a6d622025-07-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72104-042-01721040042011 JAR in 1 CARTON (72104-042-01) / 60 g in 1 JAR1 jar2025-01-13NoNoCurrent