NELLY DEVUYST ORGANIC TRANSPARENT MINERAL SUNSCREEN SPF30- titanium dioxide, zinc oxide cream

NELLY DEVUYST ORGANIC TRANSPARENT MINERAL SUNSCREEN by

Drug Labeling and Warnings

NELLY DEVUYST ORGANIC TRANSPARENT MINERAL SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by LABORATOIRES DRUIDE INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients

Titanium Dioxide 2.0%

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 and evenly 15 minutes before sun 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 this 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 ▪ Use a water-resistant sunscreen if swimming or sweating.

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

Glyceryl Stearate, Withania Somnifera Root Extract*, Fagus Sylvatica Bud Extract, C10-18 Triglycerides, Sodium Citrate, Panax Ginseng Extract, Sorbic Acid, Tocopherol, Propanediol, Potassium Sorbate, Sodium Stearoyl Glutamate, Hyaluronate Sodium, Hyaluronate Sodium, Aloe Barbadensis Leaf Juice*, Acmella Oleracea Extract, Coco-Caprylate, Alumina, Glycerin, Stearic Acid, Xanthan Gum, Lecithin, Polyhydroxystearic Acid, Polyglycery1-3 Polyricinoleate, Salicylic Acid, Ascorbyl Glucoside, Water (Aqua), Benzyl Alcohol, Isostearic Acid, Kaolin, Caprylic/Capric/ Linoleic Triglyceride, Fructose, Benzaldehyde.

*Certified Organic.

Questions or Comments?

1-800-263-8888

Outside Canada or the United States dial 514-333-8282 or visit www.nellydevuyst.com

NELLY DEVUYST TRANSPARENT ORGANIC SPF30 MINERAL SUNSCREEN 100G (NDC:

71447-100-00)

INGREDIENTS AND APPEARANCE

NELLY DEVUYST ORGANIC TRANSPARENT MINERAL SUNSCREEN  SPF30
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71447-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
FRUCTOSE (UNII: 6YSS42VSEV)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
SORBIC ACID (UNII: X045WJ989B)
TOCOPHEROL (UNII: R0ZB2556P8)
PROPANEDIOL (UNII: 5965N8W85T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ACMELLA OLERACEA FLOWERING TOP (UNII: 1O11RD9U53)
COCO-CAPRYLATE (UNII: 4828G836N6)
BENZALDEHYDE (UNII: TA269SD04T)
ALUMINUM OXIDE (UNII: LMI26O6933)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
XANTHAN GUM (UNII: TTV12P4NEE)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
SALICYLIC ACID (UNII: O414PZ4LPZ)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ISOSTEARIC ACID (UNII: X33R8U0062)
KAOLIN (UNII: 24H4NWX5CO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71447-100-01	1 in 1 BOX	10/01/2019
1	NDC: 71447-100-00	100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/01/2019

Labeler - LABORATOIRES DRUIDE INC (245815014)

Registrant - LABORATOIRES DRUIDE INC (245815014)

Establishment
Name	Address	ID/FEI	Business Operations
EUROPE SKIN CARE AVENUE CORP		117190623	pack(71447-100)

Establishment
Name	Address	ID/FEI	Business Operations
7774672 CANADA INC		203095039	pack(71447-100)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATOIRES DRUIDE INC		245815014	manufacture(71447-100)