1926 SINCE DERM ACTE 365 UV SCREEN SPF30- titanium dioxide, zinc oxide cream 
LABORATOIRES DRUIDE 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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1926 SINCE DERM ACTE 365 UV SCREEN FPS30 SUNSCREEN 50 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

on damaged or broken skin.

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, 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.

Questions or Comments?

1-800-561-3634
or visit www.academiebeaute.ca

1923 SINCE DERM ACTE 365 UV SCREEN CREAM SUNSCREEN SPF30 50ML (71447-055-01)

1923 SINCE DERM ACTE 365 UV SCREEN CREAM SUNSCREEN SPF30 50ML

1926 SINCE DERM ACTE 365 UV SCREEN  SPF30
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71447-055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71447-055-0150 mL in 1 TUBE; Type 0: Not a Combination Product07/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02007/16/2023
Labeler - LABORATOIRES DRUIDE INC (245815014)
Registrant - LABORATOIRES DRUIDE INC (245815014)
Establishment
NameAddressID/FEIBusiness Operations
LABORATOIRES DRUIDE INC245815014manufacture(71447-055)

Revised: 7/2023
Document Id: 00e99b98-80d4-6d3e-e063-6394a90aeea4
Set id: 009eb3d1-e213-6b6a-e063-6394a90afef3
Version: 2
Effective Time: 20230720
 
LABORATOIRES DRUIDE INC