Label: 1926 SINCE DERM ACTE 365 UV SCREEN SPF30- titanium dioxide, zinc oxide cream
- NDC Code(s): 71447-055-01
- 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 July 20, 2023
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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
-
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, C10-18 TRIGLYCERIDES, PROPANEDIOL, COCO-CAPRYLATE/CAPRATE, POLYHYDROXYSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, ISOSTEARIC ACID, LECITHIN, SODIUM CITRATE, GLYCERYL STEARATE, SODIUM HYALURONATE, PANAX GINSENG EXTRACT*, GLYCERIN, SODIUM STEAROYL GLUTAMATE, XANTHAN GUM, SALICYLIC ACID, TOCOPHEROL, STEARIC ACID, PARFUM (NATURAL), POTASSIUM SORBATE, ALUMINA, BENZYL ALCOHOL, SORBIC ACID.
*Certified Organic.
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- 1923 SINCE DERM ACTE 365 UV SCREEN CREAM SUNSCREEN SPF30 50ML (71447-055-01)
-
INGREDIENTS AND APPEARANCE
1926 SINCE DERM ACTE 365 UV SCREEN SPF30
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71447-055 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 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 18.4 g in 100 mL Inactive Ingredients Ingredient Name Strength FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) SORBIC ACID (UNII: X045WJ989B) TOCOPHEROL (UNII: R0ZB2556P8) PROPANEDIOL (UNII: 5965N8W85T) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) ALOE VERA LEAF (UNII: ZY81Z83H0X) COCO-CAPRYLATE (UNII: 4828G836N6) GLYCERIN (UNII: PDC6A3C0OX) STEARIC ACID (UNII: 4ELV7Z65AP) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6) SALICYLIC ACID (UNII: O414PZ4LPZ) ISOSTEARIC ACID (UNII: X33R8U0062) C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI) SODIUM CITRATE (UNII: 1Q73Q2JULR) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0) XANTHAN GUM (UNII: TTV12P4NEE) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ALUMINUM OXIDE (UNII: LMI26O6933) CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71447-055-01 50 mL in 1 TUBE; Type 0: Not a Combination Product 07/16/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 07/16/2023 Labeler - LABORATOIRES DRUIDE INC (245815014) Registrant - LABORATOIRES DRUIDE INC (245815014) Establishment Name Address ID/FEI Business Operations LABORATOIRES DRUIDE INC 245815014 manufacture(71447-055)
