Label: NELLY DEVUYST ORGANIC SUNSCREEN NATURAL PROTECTION BROAD SPECTRUM SPF30- titanium dioxide, zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71447-002-01 - 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 June 5, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- NELLY DEVUYST ORGANIC CREAM SUNSCREEN NATURAL PROTECTION BROAD SPECTRUM SPF30
- 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*, 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?
- NELLY DEVUYST ORGANIC CREAM SUNSCREEN NATURAL PROTECTION BROAD SPECTRUM SPF30 120g (71447-002-01)
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INGREDIENTS AND APPEARANCE
NELLY DEVUYST ORGANIC SUNSCREEN NATURAL PROTECTION BROAD SPECTRUM SPF30
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71447-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 65 g in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 63 g in 1 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:71447-002-01 120 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 7774672 CANADA INC 203095039 pack(71447-002) Establishment Name Address ID/FEI Business Operations LABORATOIRES DRUIDE INC 245815014 manufacture(71447-002)
