NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN SPF30- zinc oxide cream

NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN by

Drug Labeling and Warnings

NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED 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 (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

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*, C10-18 Triglycerides, Caprylic/Capric Triglyceride, Glycerin (Vegetal), Propanediol, Coco-Caprylate/Caprate, Silica, Polyglyceryl-6 Distearate, Polyhydroxystearic Acid, Sodium Citrate, Citric Acid, Glyceryl Stearate, Sodium Hyaluronate, Aesculus Hippocastanum (Horse Chestnut) Extract, Acmella Oleracea Extract, Fagus Sylvatica Bud Extract, Ascorbyl Glucoside (Vitamin C), Withania Somnifera Root Extract, Camellia Sinensis Leaf Extract, Coffea Arabica (Coffee) Leaf/Seed Extract, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Cinnamomum Cassia Bark Extract, Rose Extract, Prunus Armeniaca (Apricot) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Glycine Soja (Soybean) Oil, Eugenia Caryophyllus (Clove) Flower Extract, Cucumis Melo Cantalupensis Fruit Extract, Orchis Mascula Flower Extract, Cananga Odorata Flower Extract, Jojoba Esters, Sodium Stearoyl Glutamate, Xanthan Gum, Salicylic Acid, Polyglyceryl-3 Beeswax, Cetyl Alcohol, Tocopherol (Vitamin E), Octyldodecanol, Parfum (Natural), Benzyl Alcohol, Trihydroxystearin, Potassium Sorbate, Alumina, Stearic Acid, Cananga Odorata Flower Oil*, Sorbic Acid, Citrus Medica Limonum (Lemon) Peel Oil*, Water (Aqua), Kigelia Africana Fruit Extract, Quillaja Saponaria Bark Extract, Alpha-Glucan Oligosaccharide, Glycogen, Fructose, CI 77891, CI 77492, CI 77491, CI 77499.

*Certified organic.

Questions or Comments?

Call 1-800-263-8888
or visit www.nellydevuyst.com

NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN SPF30 30mL (NDC:

71447-033-00)

INGREDIENTS AND APPEARANCE

NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN  SPF30
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71447-033
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
GLYCOGEN (UNII: 309GSC92U1)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y)
ACMELLA OLERACEA FLOWERING TOP (UNII: 1O11RD9U53)
FAGUS SYLVATICA FLOWER BUD (UNII: 6D5V13045W)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q)
JASMINUM OFFICINALE LEAF (UNII: 6OG06384ID)
CINNAMOMUM CASSIA TWIG (UNII: 4UD6VQR2UP)
ROSE OIL (UNII: WUB68Y35M7)
PRUNUS ARMENIACA SEED (UNII: 75356789IW)
APPLE (UNII: B423VGH5S9)
SOYBEAN OIL (UNII: 241ATL177A)
CLOVE (UNII: K48IKT5321)
CANTALOUPE (UNII: 8QF5D5H6UH)
ORCHIS MASCULA FLOWER (UNII: 6H1JQK35LA)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
SALICYLIC ACID (UNII: O414PZ4LPZ)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STEARIC ACID (UNII: 4ELV7Z65AP)
CETYL ALCOHOL (UNII: 936JST6JCN)
KIGELIA AFRICANA FRUIT (UNII: L4J6XXD1E0)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
FRUCTOSE (UNII: 6YSS42VSEV)
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
CANANGA ODORATA FLOWER (UNII: 76GTF6Z97M)
SORBIC ACID (UNII: X045WJ989B)
TOCOPHEROL (UNII: R0ZB2556P8)
OCTYLDODECANOL (UNII: 461N1O614Y)
FRAGRANCE FRESH CITRUS FLORAL ORC1501495 (UNII: OU4GI2R2WB)
XANTHAN GUM (UNII: TTV12P4NEE)
LEMON OIL (UNII: I9GRO824LL)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CANANGA ODORATA LEAF OIL (UNII: 6W864D0X3X)
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
ALUMINUM OXIDE (UNII: LMI26O6933)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71447-033-01	1 in 1 BOX	05/27/2024
1	NDC: 71447-033-00	30 mL 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 Drug	M020	05/27/2024

Labeler - LABORATOIRES DRUIDE INC (245815014)

Registrant - LABORATOIRES DRUIDE INC (245815014)

Establishment
Name	Address	ID/FEI	Business Operations
LABORATOIRES DRUIDE INC		245815014	manufacture(71447-033)