NELLY DE VUYST BRUXELLES SPF 30 BROAD SPECTRUM SUNSCREEN- sunscreen cream 
7774672 CANADA 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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NELLY DE VUYST BRUXELLES SPF 30 BROAD SPECTRUM SUNSCREEN 3.3 Oz (100g)

DRUG FACTS

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2%

Oxybenzone 2.5%

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 Poison Control Center right away.

Directions

■ apply liberally 15 minutes before exposure, reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours.

■ Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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

■ Children under 6 months of age: ask a doctor.

Inactive Ingredients

1,2 hexanediol, behenyl alcohol, BHT, butyloctyl salicylate, calcium pantothenate, caprylyl glycol, caprylyl methicone, dimethicone, dimethyl capramide, disodium edta, ethylhexylstearate, ethylhexylglycerin, glycerin, glyceryl stearate, lecithin, lepidium sativum sprout extract, maltodextrin, niacinamide, peg-100 stearate, phenoxyethanol, polyester-8, pyridoxine HCl, silica, sodium ascorbyl phosphate, sodium polyacrylate, sodium starch octenylsuccinate, styrene / acrylates copolymer, tocopheryl acetate, trideceth-6, trimethylsiloxysilicate, VP/hexadecene copolymer, water, xanthan gum

Questions or Comments?

Call 1-800-263-8888 or visit www.nellydevuyst.com, www.derme.ca

Distributed by:

7774672 Canada Inc

Derme & Co

4980 Chemin Bois Franc

St Laurent QC H4S 1A7

Canada

MADE IN CANADA

NELLY DEVUYST BRUXELLES SPF 30 BROAD SPECTRUM SUNSCREEN 3.3 Oz (100g) (58416-002)

Nelly Devuys Bruxelles Sunscreen

NELLY DE VUYST BRUXELLES SPF 30 BROAD SPECTRUM SUNSCREEN 
sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58416-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.1 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DOCOSANOL (UNII: 9G1OE216XY)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
WATER (UNII: 059QF0KO0R)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
NIACINAMIDE (UNII: 25X51I8RD4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58416-002-001 in 1 CARTON10/21/2018
1100 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/21/201804/13/2019
Labeler - 7774672 CANADA INC (203095039)
Registrant - 7774672 CANADA INC (203095039)
Establishment
NameAddressID/FEIBusiness Operations
7774672 CANADA INC203095039manufacture(58416-002) , label(58416-002) , pack(58416-002)

Revised: 4/2019
Document Id: 866a906d-345b-8468-e053-2991aa0a672c
Set id: 78d26f6c-ee3e-45fc-e053-2991aa0a5b83
Version: 2
Effective Time: 20190413
 
7774672 CANADA INC