Label: DR.JART EVERY SUN DAY MINERAL SUN SCREEN- titanium dioxide, zinc oxide cream
- NDC Code(s): 49404-306-01, 49404-306-02
- Packager: Have & Be Co., Ltd.
- 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 August 11, 2023
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- Active ingredients
- Purpose
- Use
- Wanings
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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
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR.JART EVERY SUN DAY MINERAL SUN SCREEN
titanium dioxide, zinc oxide creamProduct 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 final 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)
Every Sun Day