G.M. Collin SPF 50 Broad Spectrum Mineral Sunscreen

G.M. Collin by

Drug Labeling and Warnings

G.M. Collin by is a Otc medication manufactured, distributed, or labeled by Laboratoires Dermo-Cosmetik Inc., Le Conditionnement Belge. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

G.M. COLLIN  SPF 50 BROAD SPECTRUM MINERAL SUNSCREEN- titanium dioxide lotion 
Laboratoires Dermo-Cosmetik Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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G.M. Collin
SPF 50 Broad Spectrum Mineral Sunscreen

Product Facts / Drug Facts

Active ingredient

Titanium Dioxide 15.9%

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. Shake well before each use.

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

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?

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

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

PRINCIPAL DISPLAY PANEL - 100 ml Tube Carton

G.M.
COLLIN®
PARIS

SPF
50
UVAUVB

HIGH PROTECTION VEIL

BROAD SPECTRUM
MINERAL SUNSCREEN

NDC: 64127-214-01
NPN 800XXXXXX

100 ml - 3.4 fl. oz.

G.M. COLLIN   SPF 50 BROAD SPECTRUM MINERAL SUNSCREEN
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64127-214
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	15.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LEVOMENOL (UNII: 24WE03BX2T)
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DIETHYL SEBACATE (UNII: I41B9FJK6V)
HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
KARUM SEED OIL (UNII: 62160PU6FJ)
SESAME OIL (UNII: QX10HYY4QV)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64127-214-01	1 in 1 CARTON	05/31/2020	12/31/2023
1		100 mL 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 NOT FINAL	part352	05/31/2020	12/31/2023

Labeler - Laboratoires Dermo-Cosmetik Inc. (249335480)

Establishment
Name	Address	ID/FEI	Business Operations
Le Conditionnement Belge		282825439	MANUFACTURE(64127-214)

Revised: 7/2023

Document Id: 74206830-6831-4e82-ad19-04f188f79e9e

34390-5

Set id: c3ddac27-651a-4f9f-b33d-e05ee47e3ba0

Version: 3

Effective Time: 20230721