Label: NELLY DEVUYST BIOSOLAR COLORLIFT 2 TINTED SUNSCREEN 30 ML SPF30- titanium dioxide, zinc oxide cream
- NDC Code(s): 71447-031-00, 71447-031-01
- Packager: LABORATOIRES DRUIDE INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 26, 2021
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Active Ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
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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
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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?
- NELLY DEVUYST BIOSOLAR COLORLIFT 2 TINTED SPF 30 SUNSCREEN 30 mL (NDC 71447-031-00)
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INGREDIENTS AND APPEARANCE
NELLY DEVUYST BIOSOLAR COLORLIFT 2 TINTED SUNSCREEN 30 ML SPF30
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71447-031 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:71447-031-01 1 in 1 BOX 04/26/2021 1 NDC:71447-031-00 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 Labeler - LABORATOIRES DRUIDE INC (245815014) Registrant - LABORATOIRES DRUIDE INC (245815014) Establishment Name Address ID/FEI Business Operations LABORATOIRES DRUIDE INC 245815014 manufacture(71447-031)
