NELLY DEVUYST ORGANIC SUNSCREEN NATURAL PROTECTION BROAD SPECTRUM SPF30- titanium dioxide, zinc oxide cream 
LABORATOIRES DRUIDE 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 ORGANIC CREAM SUNSCREEN NATURAL PROTECTION BROAD SPECTRUM SPF30

Active Ingredients

Titanium Dioxide 6.5%
Zinc Oxide 6.3%

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

ALOE BARBADENSIS LEAF JUICE*, ASPALATHUS LINERIS (ROOIBOS) EXTRACT*, ACMELLA OLERACEA EXTRACT, ASCORBYL GLUCOSIDE, AQUA, ALCOHOL, ALUMINA, BENTONITE, BENZYL ALCOHOL, COCOS NUCIFERA (COCONUT) OIL*, CARAMEL*, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCO-CAPRYLATE, CITRIC ACID, GLYCERIN, HELIANTHUS ANUUS (SUNFLOWER) OIL*, ISOSTEARIC ACID, KAOLIN, LECITHIN, PROPANEDIOL, POLYHYDROXYSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, POTASSIUM SORBATE, SODIUM STEAROYL GLUTAMATE, SODIUM HYALURONATE, SODIUM GLUCONATE, STEARIC ACID, SALICYLIC ACID, SORBIC ACID, TOCOPHEROL, XANTHAN GUM.

*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 ORGANIC CREAM SUNSCREEN NATURAL PROTECTION BROAD SPECTRUM SPF30 120g (71447-002-01)

NELLY DEVUYST ORGANIC CREAM SUNSCREEN NATURAL PROTECTION BROAD SPECTRUM SPF30

NELLY DEVUYST ORGANIC SUNSCREEN NATURAL PROTECTION BROAD SPECTRUM  SPF30
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71447-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE65 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE63 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBIC ACID (UNII: X045WJ989B)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PROPANEDIOL (UNII: 5965N8W85T)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)  
ACMELLA OLERACEA FLOWERING TOP (UNII: 1O11RD9U53)  
ALCOHOL (UNII: 3K9958V90M)  
BENTONITE (UNII: A3N5ZCN45C)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARAMEL (UNII: T9D99G2B1R)  
COCONUT OIL (UNII: Q9L0O73W7L)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
SODIUM GLUCONATE (UNII: R6Q3791S76)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
WATER (UNII: 059QF0KO0R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
KAOLIN (UNII: 24H4NWX5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71447-002-01120 g in 1 TUBE; Type 0: Not a Combination Product06/12/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/12/2017
Labeler - LABORATOIRES DRUIDE INC (245815014)
Registrant - LABORATOIRES DRUIDE INC (245815014)
Establishment
NameAddressID/FEIBusiness Operations
7774672 CANADA INC203095039pack(71447-002)
Establishment
NameAddressID/FEIBusiness Operations
LABORATOIRES DRUIDE INC245815014manufacture(71447-002)

Revised: 6/2017
Document Id: 51362275-b803-5d78-e054-00144ff8d46c
Set id: 50e66bbc-a4be-501d-e054-00144ff8d46c
Version: 4
Effective Time: 20170605
 
LABORATOIRES DRUIDE INC