NELLY DEVUYST MINERAL SPF 30 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 DEVUYST MINERAL SPF 30 SUNSCREEN 4.23 Oz (120g)

DRUG FACTS

Active Ingredients

Titanium Dioxide (Non-Nano) 2%

Zinc Oxide 18.4%

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 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

Aloe Barbadensis Leaf Juice*, C10-18 Triglycerides, Caprylic/Capric Triglyceride, Propanediol, Coco-Caprylate, Polyglyceryl-6 Distearate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Glyceryl Stearate, Sodium Citrate, Sodium Hyaluronate, Panax Ginseng Root Extract*, Acmella Oleracea Extract, Fagus Sylvatica Bud Extract, Ascorbyl Glucoside, Withania Somnifera Root Extract, Fructose, Jojoba Esters, Kaolin, Sodium Stearoyl Glutamate, Xanthan Gum, Salicylic Acid, Polyglyceryl-3 Beeswax, Cetyl Alcohol, Glycerin, Tocopherol, Aroma, Benzyl Alcohol, Potassium Sorbate, Alumina, Stearic Acid, Sorbic Acid, Water (Aqua).

*Certified Organic

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 MINERAL SPF 30 SUNSCREEN 3.3 Oz (120g) (58416-003)

Nelly Devuyst Mineral SPF30 Sunscreen

NELLY DEVUYST MINERAL SPF 30 SUNSCREEN 
sunscreen cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58416-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18.4 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
TOCOPHEROL (UNII: R0ZB2556P8)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
ALOE (UNII: V5VD430YW9)  
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
PROPANEDIOL (UNII: 5965N8W85T)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
POLYGLYCERYL-3 OLEATE (UNII: XRQ165498B)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)  
FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)  
FRUCTOSE (UNII: 6YSS42VSEV)  
JOJOBA OIL GLYCERETH-8 ESTERS (UNII: 435WC6V33R)  
KAOLIN (UNII: 24H4NWX5CO)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
XANTHAN GUM (UNII: TTV12P4NEE)  
GLYCERIN (UNII: PDC6A3C0OX)  
ACMELLA OLERACEA FLOWER (UNII: 2794N5KM0K)  
SORBIC ACID (UNII: X045WJ989B)  
WATER (UNII: 059QF0KO0R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BENZALDEHYDE (UNII: TA269SD04T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58416-003-001 in 1 BOX01/27/2019
1120 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/27/201904/13/2019
Labeler - 7774672 CANADA INC (203095039)
Registrant - 7774672 CANADA INC (203095039)
Establishment
NameAddressID/FEIBusiness Operations
7774672 CANADA INC203095039manufacture(58416-003) , label(58416-003) , pack(58416-003)

Revised: 4/2019
 
7774672 CANADA INC