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 87 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CabanaMilk Mineral Barrier Fluid SPF 50ZINC OXIDENAKED SUNDAYS PTY LTD47d0fe4d-ad21-1004-e063-6394a90a9c192026-01-07WarningsExact identifier
application number: M020
CENTELLA RELIEF SOOTHING SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEIUNIK Co., Ltd.47d170e3-dd76-d413-e063-6294a90ae8e42026-01-07WarningsExact identifier
application number: M020
Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad SpectrumZINC OXIDESEORIN COMPANY Co., Ltd.1e7cc417-3c57-c87c-e063-6394a90a670b2026-01-07WarningsExact identifier
application number: M020
Proactiv Clear Skin SPF 30AVOBENZONE, OCTISALATE, AND OCTOCRYLENEAlchemee, LLCb0aa7ff0-f712-486f-aaaf-f88fed3b5cd12026-01-07WarningsExact identifier
application number: M020
Daily Hydrating Mineral Body Sunscreen Broad Spectrum SPF 30 SunscreenZINC OXIDEOak Essentials, LLC47d37f44-10b2-214f-e063-6294a90a5abc2026-01-07WarningsExact identifier
application number: M020
PLUMSCREEN SPF 31ZINC OXIDELe Prunier Farms, Inc.e20eb996-2b64-6bd0-e053-2a95a90a4f922026-01-07WarningsExact identifier
application number: M020
BETA-GLUCAN MILD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEIUNIK Co., Ltd47d6ad8b-1081-ee21-e063-6294a90a0e632026-01-07WarningsExact identifier
application number: M020
Koobarra Mineral Face Sunscreen SPF 50ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED37cf8143-99f2-cca5-e063-6394a90a19a82026-01-07WarningsExact identifier
application number: M020
Solar Swipe Mineral Sunscreen SPF50SOLAR SWIPE MINERAL SUNSCREEN SPF50Guangzhou Fantesy Biotechnology Co.,Ltd47d75d61-5295-3eab-e063-6394a90a01c12026-01-07WarningsExact identifier
application number: M020
LUXURY SUN RITUAL PORE SMOOTHING SPF 30 SUNSCREENZINC OXIDEJANE STREET LLCdbdd3e6a-f09d-90cf-e053-2a95a90a98a02026-01-07WarningsExact identifier
application number: M020
RENEWALUXE SPF 50 SunscreenRENEWALUXE SPF 50 SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd1bc29960-5e73-e8ab-e063-6294a90a3f802026-01-06WarningsExact identifier
application number: M020
ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREENSPF50Wild Child Laboratories PTY Ltd2767ba3e-7434-d474-e063-6294a90aa4ff2026-01-06WarningsExact identifier
application number: M020
ULTRA VIOLETTE SPF ON THE GLOW Duo Pack KitSPF 50Grace And Fire USA Inc.47b7da8a-ea89-1402-e063-6294a90a23f92026-01-06WarningsExact identifier
application number: M020
Hawaiian Blend Essential Zinc SPF 30ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group5a6e622f-2c00-406a-8860-d7081656f5972026-01-06WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Neutral 5OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION66c22f17-5418-42ff-97b2-33fa10f5eac32026-01-06WarningsExact identifier
application number: M020
SHISEIDO BENEFIANCE WRINKLERESIST24 DAYAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION7d9c0f81-005f-4223-940e-a64143db52752026-01-06WarningsExact identifier
application number: M020
SHISEIDO FUTURE Solution LX INFINITE TREATMENT PRIMERTITANIUM DIOXIDE, OCTINOXATE, AND ENSULIZOLESHISEIDO AMERICAS CORPORATIONff088b0c-27c9-4ea8-bf94-6261378c71902026-01-06WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 50 (physical filters)SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)31e976a2-0623-0dca-e063-6394a90a08da2026-01-06WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING TINT 115 Fair ShirakabaOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION26151cf4-0fee-4a42-92fd-4d7b9cef83812026-01-06WarningsExact identifier
application number: M020
Drs. pharmacy sunscreen SPF 50 (physical filters)SUNSCREEN SPF 50OL PHARMA TECH LLC. (Drs. Pharmacy)315a5ca4-4536-d585-e063-6294a90a1c502026-01-06WarningsExact 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