1926 SINCE DERM ACTE 365 UV SCREEN SPF30- titanium dioxide, zinc oxide cream

1926 SINCE DERM ACTE 365 UV SCREEN by

Drug Labeling and Warnings

1926 SINCE DERM ACTE 365 UV SCREEN 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 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)

INGREDIENTS AND APPEARANCE

1926 SINCE DERM ACTE 365 UV SCREEN  SPF30
titanium dioxide, zinc oxide cream

Product 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)