G.M. COLLIN FPS-SPF 45 UVA-UVB TINTED SUNSCREEN- zinc oxide, titanium dioxide cream

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

Drug Labeling and Warnings

G.M. Collin FPS-SPF 45 UVA-UVB TINTED SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by LABORATOIRES DERMO-COSMETIK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse
with water to remove.

Stop use and ask a doctor if rash occurs.

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

G.M. COLLIN FPS-SPF 45 UVA-UVB TINTED SUNSCREEN 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64127-244
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	11.2 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
SOLANUM LYCOPERSICUM FRUITING TOP (UNII: X636CG4BH0)
RICE BRAN (UNII: R60QEP13IC)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
APRICOT KERNEL OIL (UNII: 54JB35T06A)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LUPINUS ALBUS SEED OIL (UNII: 958BJW095Q)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
WHEAT GERM OIL UNSAPONIFIABLES (UNII: 6AXM7XCV3D)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CARNAUBA WAX (UNII: R12CBM0EIZ)
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
STEARIC ACID (UNII: 4ELV7Z65AP)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64127-244-01	1 in 1 CARTON	01/01/2024
1		50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/01/2024

Labeler - LABORATOIRES DERMO-COSMETIK INC. (249335480)