FDA.reportPublic FDA data

GM Collin

Product NDC
64127-234
11-digit product format
641270234
Labeler code
64127
Product ID
64127-234_463f762a-9c1a-8658-e063-6294a90a1b72
Type
HUMAN OTC DRUG
Nonproprietary name
zinc oxide and titanium dioxide
Dosage form
CREAM
Route
TOPICAL
Labeler
Laboratoires Dermo-Cosmetik Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-15
Substance
ZINC OXIDE; TITANIUM DIOXIDE
Active strength
14.6; 4.2 mg/100mL; mg/100mL
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
GM Collin
Brand name suffix
SPF 25 UVA - UVB Urban Protection Veil Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE14.6 mg/100mL
TITANIUM DIOXIDE4.2 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f0d44ca-09f0-4feb-b78c-77d83e75d4e2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64127-234-01GM CollinSPF 25 UVA - UVB Urban Protection Veil Sunscreen1 in 1 BOXCREAM14
64127-234-01GM CollinSPF 25 UVA - UVB Urban Protection Veil Sunscreen100 mL in 1 BOTTLE, PLASTICCREAM1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64127-234GM COLLIN SPF 25 UVA - UVB URBAN PROTECTION VEIL SUNSCREEN (ZINC OXIDE AND TITANIUM DIOXIDE) CREAM [LABORATOIRES DERMO-COSMETIK INC.]3Current NDC, Legacy NDC, 2 package rows20231030_4f0d44ca-09f0-4feb-b78c-77d83e75d4e2.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 48 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avebonzone, Homosalate, OctisalateAVEBONZONE, HOMOSALATE, OCTISALATEAmazon.com Services LLC4ab6773f-00e1-897a-e063-6294a90ab0b82026-04-06Warnings, Adverse reactionsExact identifier
application number: M020
Principal Secret Revolutionary Anti-Aging Broad Spectrum SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENEGuthy-Renker LLCeb1a9b67-b9e2-41f8-bc6d-df94b6a33ab82026-04-06WarningsExact identifier
application number: M020
TIRTIR HYDRO UV SHIELD SUNSCREEN SPF50 BROAD SPECTRUMHOMOSALATE, AVOBENZONE, OCTISALATE, OCTOCRYLENETIRTIR USA Inc.4ec04105-e54f-a82e-e063-6394a90a6c5a2026-04-05WarningsExact identifier
application number: M020
PRVWORA Ultra Defense SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENECellarkbio Inc.50cf1d88-3e7e-47b7-816a-3d579bde0a6a2026-04-04WarningsExact identifier
application number: M020
EltaMD UV Shield SPF45ZINC OXIDE AND OCTINOXATE SUNSCREENCP Skin Health Group, Inc.7c49f971-d425-4be9-a665-5cd218b7f9452026-04-03WarningsExact identifier
application number: M020
Jack BlackAVOBENZONE/HOMOSALATE/OCTISALATE/PETROLATUMJack Black L.L.C.4baade5c-e759-d98f-e063-6394a90aa0562026-04-03WarningsExact identifier
application number: M020
Vacation SPF 30 ClassicSprayAVOBENZONE, OCTISALATE, OCTOCRYLENEVacation Inc.da43d71d-733b-5700-e053-2a95a90a5dca2026-04-03WarningsExact identifier
application number: M020
Warriors Crown Sentinel Zinc Defense Sunscreen SPF 30ZINC OXIDEAllure Labs4e93e64a-97ab-e0a5-e063-6294a90ad9502026-04-03WarningsExact identifier
application number: M020
Pro-Collagen Marine Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, AND OCTOCRYLENEELEMIS Limited3321281e-612b-4305-bf6d-bfab02c65ffb2026-04-03WarningsExact identifier
application number: M020
EltaMD Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
application number: M020
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc4fc18856-01b3-43ed-9e1b-b4394e31aa3c2026-04-03WarningsExact identifier
application number: M020
Sunscreen for baby SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co., Ltd.1cb7fbca-0874-ae53-e063-6294a90ab42a2026-04-02WarningsExact identifier
application number: M020
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD4e7bdec2-abcc-0267-e063-6394a90ae47a2026-04-02WarningsExact identifier
application number: M020
TIZO PHOTOCEUTICAL AM REPLENISH - TINTEDZINC OXIDEFallien Cosmeceuticals, LTD4e7c4702-5707-6c3e-e063-6394a90a05fd2026-04-02WarningsExact identifier
application number: M020
Ilia Sun Serum Mineral Sunscreen SPF 50 Light MediumZINC OXIDEIlia, Inc.4e7cc73c-d6c9-ecb0-e063-6394a90a922c2026-04-02WarningsExact identifier
application number: M020
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc17b47994-82d6-4f9d-8249-bdb55106c9b32026-04-02WarningsExact identifier
application number: M020
Hand Sunscreen CreamAVOBENZONE, OCTISALATE, OCTOCRYLENEJiangsu Senwo Medical Technology Co., Ltd.4e615757-76b1-8f34-e063-6394a90a280a2026-04-01WarningsExact identifier
application number: M020
All Good Mineral Sport Sunscreen Sunstick SPF 30ZINC OXIDEElemental Herbs, Inc.4e67b76e-b791-4e26-e063-6294a90aa9912026-04-01WarningsExact identifier
application number: M020
All Good Coconut Mineral Sunscreen Sunstick SPF 30ZINC OXIDEElemental Herbs, Inc.4e67e89b-a7be-a540-e063-6294a90a6d8f2026-04-01WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAYAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEShiseido Americas Corporationcad3a446-36a8-4146-81b5-1cc8d65abf142026-04-01WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64127-234-01641270234011 BOTTLE, PLASTIC in 1 BOX (64127-234-01) / 100 mL in 1 BOTTLE, PLASTIC2021-01-150000-00-00NoNoCurrent