G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN

Product NDC: 64127-244
11-digit product format: 641270244
Labeler code: 64127
Product ID: 64127-244_458b7274-da08-6bf7-e063-6394a90a4881
Type: HUMAN OTC DRUG
Nonproprietary name: zinc oxide, titanium dioxide
Dosage form: CREAM
Route: TOPICAL
Labeler: LABORATOIRES DERMO-COSMETIK INC.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-01-01
Substance: ZINC OXIDE; TITANIUM DIOXIDE
Active strength: 8.4; 11.2 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: G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	8.4 g/100g
TITANIUM DIOXIDE	11.2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
15FIX9V2JP	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
01dcfd14-7a1d-98fa-e063-6294a90a0336	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64127-244-01	G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN	50 g in 1 BOTTLE, PUMP	CREAM	50		3
64127-244-01	G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN	1 in 1 CARTON	CREAM	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64127-244	G.M. COLLIN FPS-SPF 45 UVA-UVB TINTED SUNSCREEN (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [LABORATOIRES DERMO-COSMETIK INC.]	2	Current NDC, 2 package rows	20250303_01dcfd14-7a1d-98fa-e063-6294a90a0336.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 107 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	090904d1-c04c-3fca-e063-6294a90a7cc7	2025-12-18	Warnings	Exact identifier application number: M020
Bye Bye Foundation Full Coverage Moisturizer SPF 50 Fair	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	b098aba3-dad6-4421-a943-e88ce5e2f8d6	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Ivory Fair Warm Fair Beige Medium Tan Warm Tan Rich Neutral Rich Neutral Deep Deep Bronze Deep Honey Deep Mocha	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	b3260833-8b7c-4d88-a55a-8cef4938442d	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Medium Tan Neutral Rich	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	0a647c9a-2c71-4cd2-9503-e9ab96b857ee	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Fair Light LightMedium Medium Tan TanRich RichDeep	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	f246553e-17c2-4dba-855b-1942646bb834	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Medium Tan Warm Neutral Rich Deep Bronze Neutral Deep Deep Bronze	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	15de58a4-e2bc-425b-b50b-df2d87dd3bb4	2025-12-18	Warnings	Exact identifier application number: M020
it cosmetics Your Skin But Better CC Plus Illumination Color Correcting Illuminating Broad Spectrum SPF 50 Plus Sunscreen Full Coverage FairLight NeutralTan RichHoney LightMedium and NeutralMedium	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	f493c3ea-41b3-4625-84a6-fab545a76940	2025-12-18	Warnings	Exact identifier application number: M020
YOUR SKIN BUT BETTER FAIR	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	472f34c5-cefe-4884-9475-fd0666c925ac	2025-12-18	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Broad Spectrum Sunscreen SPF 30	OCTINOXATE, OCTOCRYLENE, AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	d7238996-374b-07aa-e053-2995a90ae889	2025-12-18	Warnings	Exact identifier application number: M020
Olay Regenerist Hyaluronic plus Peptide 24 Hydrating Moisturizer with Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	eadacdae-3901-3f7c-e053-2a95a90ab184	2025-12-18	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Ultra Repair Face Moisturizer with Sunscreen Broad Spectrum SPF 30	OCTOCRYLENE, AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	f6801575-6081-7566-e053-2995a90a20a8	2025-12-18	Warnings	Exact identifier application number: M020
Olay Regenerist Regenerating with Sunscreen Broad Spectrum SPF 15	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	00280745-908b-468f-e063-6294a90aa12f	2025-12-18	Warnings	Exact identifier application number: M020
OLAY Prime plus Protect Facial Sunscreen with Vitamin C SPF35 Matte Finish	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	10bd41ac-9b96-840d-e063-6394a90a98d9	2025-12-18	Warnings	Exact identifier application number: M020
Olay Glow plus Protect Sunscreen Dewy Glow SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE	The Procter & Gamble Manufacturing Company	10bc4127-7569-d0de-e063-6294a90a97bf	2025-12-18	Warnings	Exact identifier application number: M020
First Aid Beauty FAB Hydrating Sunscreen Milk Broad Spectrum SPF 45	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	29645d90-a444-4090-e063-6294a90ac7e3	2025-12-18	Warnings	Exact identifier application number: M020
Skin On Skin BC Foundation SPF 40 - Tan Golden	OCTISALATE, HOMOSALATE, ZINC OXIDE	YENSA Beauty, LLC	46440bac-de69-e59c-e063-6394a90a76c0	2025-12-18	Warnings	Exact identifier application number: M020
FUSIDYNE DERMA TROUBLE Zinc Calming Sunscreen	ZINC OXIDE	DONG WHA PHARM. CO., LTD.	46457c78-74d6-ea6a-e063-6294a90a24ac	2025-12-18	Warnings	Exact identifier application number: M020
THE MUG GUARD Invisible Gel Suncare for Face	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Dune Suncare, Inc.	4646988c-1060-ed5f-e063-6394a90aa765	2025-12-18	Warnings	Exact identifier application number: M020
Sage and Zinc Facial Hydrating SPF15	ZINC OXIDE	Emeis Cosmetics Pty Ltd	ccabd647-ecdd-7230-e053-2a95a90a7a96	2025-12-18	Warnings	Exact identifier application number: M020
Avail Facial Sunscreen SPF 25	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Emeis Cosmetics Pty Ltd	7be903e4-5f07-35b2-e053-2991aa0a1340	2025-12-17	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
64127-244-01	64127024401	1 BOTTLE, PUMP in 1 CARTON (64127-244-01) / 50 g in 1 BOTTLE, PUMP	2024-01-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GM Collin SPF45 TINTED SUNSCREEN	LABORATOIRES DERMO-COSMETIK INC.	2025-12-09	HUMAN OTC DRUG LABEL	3