FDA.reportPublic FDA data

G.M. Collin

Manufacturer
Laboratoires Dermo-Cosmetik Inc. | Le Conditionnement Belge
Effective date
2023-07-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:28:22

Label at a glance#

ProductG.M. Collin SPF 50 Broad Spectrum Mineral Sunscreen
Active ingredientTitanium Dioxide
Label structure11 sections

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.

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: limit time i...

Storage and handling

protect this product from excessive heat and direct sun. keep at room temperature (15 - 30°C / 59 - 86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Product Facts / Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 15.9%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only. Shake well before each use.

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

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun.
  • keep at room temperature (15 - 30°C / 59 - 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

ALUMINUM HYDROXYDE, BISABOLOL, BRASSICA CAMPESTRIS (RAPESEED) OIL, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCOS NUCIFERA OIL, DICAPRYLYL CARBONATE, DIETHYL SEBACATE, FRAGRANCE/PARFUM, HYDROGENATED COCONUT OIL, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, POLYHYDROXYSTEARIC ACID, PONGAMIA GLABRA SEED OIL, SESAMUM INDICUM SEED OIL, STEARIC ACID, TOCOPHEROL.

Questions?

OTC - QUESTIONS SECTION

USA: 1 (800) 341-1531 / CANADA: 1 (800) 361-1263

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
® LABORATOIRES DERMO-COSMETIK INC.
68 STINSON, MONTREAL, QUEBEC, CANADA H4N 2E7

PRINCIPAL DISPLAY PANEL - 100 ml Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

G.M.
COLLIN®
PARIS

SPF
50
UVA•UVB

HIGH PROTECTION VEIL

BROAD SPECTRUM
MINERAL SUNSCREEN

NDC 64127-214-01
NPN 800XXXXXX

100 ml - 3.4 fl. oz.

PRINCIPAL DISPLAY PANEL - 100 ml Tube Carton
PRINCIPAL DISPLAY PANEL - 100 ml Tube Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64127-21464127-214-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
LEVOMENOL24WE03BX2TIACT
BRASSICA RAPA SUBSP. OLEIFERA OILN4G8379626IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
DIETHYL SEBACATEI41B9FJK6VIACT
HYDROGENATED COCONUT OILJY81OXM1OMIACT
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE9229XJ4V12IACT
KARUM SEED OIL62160PU6FJIACT
SESAME OILQX10HYY4QVIACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
74206830-6831-4e82-ad19-04f188f79e9ec3ddac27-651a-4f9f-b33d-e05ee47e3ba02023-07-21WarningsExact identifier
spl id: 74206830-6831-4e82-ad19-04f188f79e9e
spl set id: c3ddac27-651a-4f9f-b33d-e05ee47e3ba0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.