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Product Facts / Drug Facts
www.gmcollin.com
DISTRIBUÉ PAR / DISTRIBUTED BY:
® LAB. DERMO-COSMETIK INC.
68 STINSON, MONTREAL, QUEBEC,
CANADA H4N 2E7
FABRIQUÉ AU CANADA /
MADE IN CANADA
G.m. Collin Fps-spf 45 Uva-uvb Tinted Sunscreen Cream
FDA Label NDC 64127-244
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Dermo-cosmetik Inc. for the product G.m. Collin Fps-spf 45 Uva-uvb Tinted Sunscreen (NDC 64127-244). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient:, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Do not use on damaged or broken skin.
Otc - When Using
When using this product keep out of eyes. Rinse
with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
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
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