NELLY DEVUYST ORGANIC NATURAL PROTECTION BROAD SPECTRUM SUNSCREEN 120 g

NELLY DEVUYST ORGANIC SUNSCREEN NATURAL PROTECTION BROAD SPECTRUM by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 NATURAL PROTECTION BROAD SPECTRUM SUNSCREEN 120 g

DRUG FACTS

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. ▪ Protect this product from excessive heat and direct sun ▪ May stain some fabrics.

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 ANNUS (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 NATURAL PROTECTION BROAD SPECTRUM SPF30 SUNSCREEN 120g (71447-002-01)

NELLY DEVUYST ORGANIC SUNSCREEN NATURAL PROTECTION BROAD SPECTRUM  SPF30
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71447-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	6.5 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71447-120-00	120 g in 1 TUBE; Type 0: Not a Combination Product	06/12/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/12/2017

Labeler - LABORATOIRES DRUIDE INC (245815014)

Registrant - LABORATOIRES DRUIDE INC (245815014)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATOIRES DRUIDE INC		245815014	manufacture(71447-120)

Revised: 1/2021

Document Id: c791b53a-9252-0d36-e053-2a95a90a4cd2

34390-5

Set id: c791b53a-9251-0d36-e053-2a95a90a4cd2

Version: 1

Effective Time: 20210101