Indications and uses
• helps prevent sunburn. • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN
- Manufacturer
- LABORATOIRES DERMO-COSMETIK INC.
- Effective date
- 2025-12-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:20:46
Label at a glance#
ProductG.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure9 sections
Dosage and administration
Adults over 18 years old: • apply liberally 15 minutes before sun exposure. • reapply at least every 2 hours • use a water-resistant sunscreen if swimming or sweating • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • li...
Storage and handling
• protect this product from excessive heat and direct sun. • keep at room temperature (15 - 30˚C / 59 - 86˚F)
Contacts and useful links#
Websitewww.gmcollin.com
www.gmcollin.com
www.gmcollin.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Product Facts / Drug Facts
Active ingredient:
Titanium Dioxide 11.2%
Zinc Oxide 8.4%
Purpose
Sunscreen
Uses
• helps prevent sunburn.
• if used as directed with other sun protection
measures (see Directions), decreases the risk of
skin cancer and early skin aging caused by the sun.
Warnings
For external use only.
OTC - DO NOT USE SECTION
Do not use on damaged or broken skin.
OTC - WHEN USING SECTION
When using this product keep out of eyes. Rinse
with water to remove.
OTC - STOP USE SECTION
Stop use and ask a doctor if rash occurs.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
If swallowed, get medical help or contact a Poison
Control Center right away.
Directions
Adults over 18 years old:
• apply liberally 15 minutes before sun exposure.
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging.
To decrease risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses.
Other information
• protect this product from excessive heat and direct sun.
• keep at room temperature (15 - 30˚C / 59 - 86˚F)
Inactive ingredients
DIMETHICONE, PEG-10 DIMETHICONE, HEXYL LAURATE, COPERNICIA CERIFERA (CARNAUBA) WAX / CIRE DE CARNAUBA, POLYSILICONE-11, ISONONYL ISONONANOATE, TRIHYDROXYSTEARIN, POLYGLYCERYL-4 ISOSTEARATE, POLYMETHYLSILSESQUIOXANE, STEARIC ACID / ACIDE STÉARIQUE, IRON OXIDES / OXYDES DE FER, PRUNUS ARMENIACA (APRICOT) KERNEL OIL / HUILE DE NOYAU D’ABRICOT, TOCOPHERYL ACETATE, LUPINUS ALBUS SEED OIL / HUILE DE GRAINES DE LUPIN, TRITICUM VULGARE (WHEAT) GERM OIL UNSAPONIFIABLES / HUILES INSAPONIFIABLES DE GERME BLÉ, SOLANUM LYCOPERSICUM (TOMATO) FRUIT/LEAF/STEM EXTRACT / EXTRAIT DE FRUIT/FEUILLE/TIGE DE TOMATE, TOCOPHEROL, ALUMINA, ETHYLENE BRASSYLATE, ORYZA SATIVA (RICE) BRAN WAX / CIRE DE SON DE RIZ, TRIETHOXYCAPRYLYLSILANE.
Questions?
USA: 1 (800) 341-1531 / CANADA: 1 (800) 361-1263
SPL UNCLASSIFIED SECTION
www.gmcollin.com
DISTRIBUÉ PAR / DISTRIBUTED BY:
® LAB. DERMO-COSMETIK INC.
68 STINSON, MONTREAL, QUEBEC,
CANADA H4N 2E7
FABRIQUÉ AU CANADA /
MADE IN CANADA
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| 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 |
Products#
Every source-derived product name is available through these pages.
- G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN
- zinc oxide, titanium dioxide
- ALUMINUM OXIDE
- ETHYLENE BRASSYLATE
- SOLANUM LYCOPERSICUM FRUITING TOP
- ALPHA-TOCOPHEROL ACETATE
- RICE BRAN
- FERRIC OXIDE YELLOW
- FERRIC OXIDE RED
- FERROSOFERRIC OXIDE
- APRICOT KERNEL OIL
- LUPINUS ALBUS SEED OIL
- TRIETHOXYCAPRYLYLSILANE
- ZINC OXIDE
- DIMETHICONE
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- WHEAT GERM OIL UNSAPONIFIABLES
- TITANIUM DIOXIDE
- TRIHYDROXYSTEARIN
- HEXYL LAURATE
- CARNAUBA WAX
- PEG-10 DIMETHICONE (220 CST)
- POLYMETHYLSILSESQUIOXANE (4.5 MICRONS)
- STEARIC ACID
- ISONONYL ISONONANOATE
- POLYGLYCERYL-4 ISOSTEARATE
- TOCOPHEROL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 64127-244 | 64127-244-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN | ZINC OXIDE, TITANIUM DIOXIDE | LABORATOIRES DERMO-COSMETIK INC. | 01dcfd14-7a1d-98fa-e063-6294a90a0336 | 2025-12-09 | Warnings | 64127-244-01 64127-244 64127024401 458b7274-da08-6bf7-e063-6394a90a4881 01dcfd14-7a1d-98fa-e063-6294a90a0336 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.