DR.JART EVERY SUN DAY MINERAL SUN SCREEN- titanium dioxide, zinc oxide cream

DR.JART EVERY SUN DAY MINERAL SUN SCREEN by

Drug Labeling and Warnings

DR.JART EVERY SUN DAY MINERAL SUN SCREEN by is a Otc medication manufactured, distributed, or labeled by Have & Be Co., Ltd., Estee Lauder Companies Inc., HK Kolmar Canada, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium Dioxide 4.10%
Zinc Oxide 11.50%

Purpose

Sunscreen

Use

Helps prevent sunburn

Wanings

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure

Reapply at least every two hours
■ Use a water resistant sunscreen if swim- ming or sweating
■ 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 Sp- ectrum SPF value of 15 or higher and other sun protection measures including:
* limit time in the sun, especially from 10 am to 2 pm
* wear long-sleeved shirts, pants, hats, and sunglasses
■ Children under 6 months of age: ask a doctor

Inactive ingredients

WATER\AQUA\EAU, CYCLOPENTASILOXANE, PROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DI-CAPRATE, LAURYL POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, METHYL METHACRYLATE CROSSPOLYMER, BUTYLOCTYL SALICYLATE, CAPRYLYL METHICONE, MAGNESIUM SULFATE, DISTEARDIMONIUM HECTORITE, 1,2-HEXANEDIOL, STEARIC ACID, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, TRIETHOXYCAPRYLYLSILANE, SORBITAN CAPRYLATE, GLYCERYL CAPRYLATE, ETHYLHEXYLGLYCERIN, CITRUS NOBILIS (MANDARIN ORANGE) PEEL OIL, LITSEA CUBEBA FRUIT OIL, CITRUS AURANTIUM DULCIS (ORANGE) OIL, ALUMINUM HYDROXIDE, LIMONENE, CITRAL, TOCOPHEROL <ILN50931>

Other information

Protect the product in this container from excessive heat and direct sunlight

PRINCIPAL DISPLAY PANEL

Every Sun Day

Mineral Sunscreen

UVA/UVB Protection

Broad Spectrum

SPF 50+

Sunscreen

50mL / 1.69 fl. oz.

INGREDIENTS AND APPEARANCE

DR.JART EVERY SUN DAY MINERAL SUN SCREEN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49404-306
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	41 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	115 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TOCOPHEROL (UNII: R0ZB2556P8)
SORBITAN MONOCAPRYLATE (UNII: 1VTA8DCP5Q)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
WATER (UNII: 059QF0KO0R)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
ORANGE OIL (UNII: AKN3KSD11B)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
CITRAL (UNII: T7EU0O9VPP)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
MANDARIN OIL (UNII: NJO720F72R)
LITSEA OIL (UNII: 2XIW34BN6O)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49404-306-01	1 in 1 CARTON	08/11/2023
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49404-306-02	5 mL in 1 TUBE; Type 0: Not a Combination Product	08/11/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/11/2023

Labeler - Have & Be Co., Ltd. (690400408)

Registrant - Estee Lauder Companies Inc. (790802086)

Establishment
Name	Address	ID/FEI	Business Operations
HK Kolmar Canada, Inc		243501959	manufacture(49404-306)