NELLY DEVUYST BIOSOLAR COLORLIFT 2 TINTED SPF 30 SUNSCREEN 30 mL

NELLY DEVUYST BIOSOLAR COLORLIFT 2 TINTED SUNSCREEN 30 mL by

Drug Labeling and Warnings

NELLY DEVUYST BIOSOLAR COLORLIFT 2 TINTED SUNSCREEN 30 mL by is a Otc medication manufactured, distributed, or labeled by 7774672 CANADA INC, EUROPE SKIN CARE AVENUE CORP, LABORATOIRES DRUIDE INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NELLY DEVUYST BIOSOLAR COLORLIFT 2 TINTED SUNSCREEN 30 ML SPF30- titanium dioxide, zinc oxide 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 BIOSOLAR COLORLIFT 2 TINTED SPF 30 SUNSCREEN 30 mL

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

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*, Caprylic/Capric Triglyceride, Glycerin (Vegetal), Propanediol, Silica, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Glyceryl Stearate, Sodium Citrate, C10-18 Tryglycerides, Coco-Caprylate, Glycogen, Sodium Hyaluronate, Ascorbyl Glucoside, Kigelia Africana Fruit Extract, Quillaja Saponaria Bark Extract,
Withania Somnifera Root Extract*, Fructose, Jojoba Esters, Sodium Stearoyl Glutamate, Alpha-Glucan Oligosaccharide,
Prunus Armeniaca (Apricot) Fruit Extract, Xanthan Gum, Citrus Aurantium Dulcis (Orange) Peel Extract, Salicylic Acid,
Citrus Paradisi (Grapefruit) Extract, Benzyl Alcohol, Aniba Rosodora (Rosewood) Wood Extract, Citrus Aurantifolia (Lime) Peel Extract, Vanilla Planifolia Fruit Extract, Potassium Sorbate, Citrus Medica Limonum (Lemon) Peel Oil*, Alumina, Octyldodecanol,
Cananga Odorata Flower Oil*, Trihydroxystearin, Stearic Acid, Sorbic Acid, Water (Aqua), Acmella Oleracea Extract,
Fagus Sylvatica Bud Extract*, Tocopherol (Vitamin E), CI 77891, CI 77492, CI 77499, CI 77491.

*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 BIOSOLAR COLORLIFT 2 TINTED SPF 30 SUNSCREEN 30 mL (NDC: 58416-031-00)

NELLY DEVUYST BIOSOLAR COLORLIFT 2 TINTED SUNSCREEN 30 ML  SPF30
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58416-031
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
PROPANEDIOL (UNII: 5965N8W85T)
FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CANANGA OIL (UNII: 8YOY78GNNX)
LIME PEEL (UNII: 544EQK5Q0W)
FRUCTOSE (UNII: 6YSS42VSEV)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
ANIBA ROSAEODORA WOOD (UNII: NE01NKA8B2)
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ACMELLA OLERACEA FLOWERING TOP (UNII: 1O11RD9U53)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
FERRIC OXIDE RED (UNII: 1K09F3G675)
TOCOPHEROL (UNII: R0ZB2556P8)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
COCO-CAPRYLATE (UNII: 4828G836N6)
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 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
SALICYLIC ACID (UNII: O414PZ4LPZ)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ISOSTEARIC ACID (UNII: X33R8U0062)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
APRICOT (UNII: 269CJD5GZ9)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)
GLYCOGEN (UNII: 309GSC92U1)
SORBIC ACID (UNII: X045WJ989B)
OCTYLDODECANOL (UNII: 461N1O614Y)
VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
KIGELIA AFRICANA FRUIT (UNII: L4J6XXD1E0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
GRAPEFRUIT PEEL (UNII: 3582N05Q44)
ORANGE PEEL (UNII: TI9T76XD44)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58416-031-01	1 in 1 BOX	04/26/2021
1	NDC: 58416-031-00	30 g in 1 TUBE; 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	04/26/2021	05/26/2021

Labeler - 7774672 CANADA INC (203095039)

Registrant - 7774672 CANADA INC (203095039)

Establishment
Name	Address	ID/FEI	Business Operations
EUROPE SKIN CARE AVENUE CORP		117190623	pack(58416-031)

Establishment
Name	Address	ID/FEI	Business Operations
7774672 CANADA INC		203095039	pack(58416-031)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATOIRES DRUIDE INC		245815014	manufacture(58416-031)

Revised: 1/2022

Document Id: e46d2694-222d-3e51-e053-2a95a90af077

34390-5

Set id: c13265fa-bf19-9b6a-e053-2995a90ac207

Version: 3

Effective Time: 20220101