Label: DR.JART EVERY SUN DAY MINERAL SUN SCREEN- titanium dioxide, zinc oxide cream
- NDC Code(s): 49404-153-01, 49404-153-02
- Packager: Have & Be Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 December 22, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Use
- Warnings
-
Directions
Apply liberally 15 minutes before sun exposure
■ Reapply at least every two hours
■ Use a water resistant sunscreen if swimming
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 Spectrum
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/DICAPRATE,
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
-
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:49404-153 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 BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) WATER (UNII: 059QF0KO0R) BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) STEARIC ACID (UNII: 4ELV7Z65AP) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) LIMONENE, (+)- (UNII: GFD7C86Q1W) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) CITRAL (UNII: T7EU0O9VPP) TOCOPHEROL (UNII: R0ZB2556P8) ORANGE OIL (UNII: AKN3KSD11B) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) SORBITAN MONOCAPRYLATE (UNII: 1VTA8DCP5Q) MANDARIN OIL (UNII: NJO720F72R) LITSEA OIL (UNII: 2XIW34BN6O) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) PROPANEDIOL (UNII: 5965N8W85T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49404-153-01 1 in 1 CARTON 12/22/2022 1 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:49404-153-02 5 mL in 1 TUBE; Type 0: Not a Combination Product 12/22/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 12/22/2022 Labeler - Have & Be Co., Ltd. (690400408) Registrant - Have & Be Co., Ltd. (690400408) Establishment Name Address ID/FEI Business Operations Kolmar Korea Co., Ltd. 689512611 manufacture(49404-153)
