Label: DR.JART PREMIUM BEAUTY BALM 03 DEEP- titanium dioxide, zinc oxide, octinoxate, octisalate cream
- NDC Code(s): 49404-141-01, 49404-141-02
- 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 21, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
DOSAGE & ADMINISTRATION
- Apply liberally 15 minutes before sun exposure.
- Use a water resistant sunscreen if swimming or sweating
- Reapply 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 am - 2 pm
– Wear long-sleeved shirts, pants, hats and
sunglasses- Children under 6 months: Ask a doctor
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
INACTIVE INGREDIENT
WATER
CYCLOPENTASILOXANE
CYCLOHEXASILOXANE
GLYCERIN
TALC
PEG-10 DIMETHICONE
IRON OXIDES(CI 77492)
C12-15 ALKYL BENZOATE
NIACINAMIDE
DIPHENYLSILOXY PHENYL TRIMETHICONE
DIPROPYLENE GLYCOL
HEXYL LAURATE
DISTEARDIMONIUM HECTORITE
MAGNESIUM SULFATE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER
DIMETHICONE
IRON OXIDES(CI 77491)
TRIETHOXYCAPRYLYLSILANE
PHENOXYETHANOL
IRON OXIDES(CI 77499)
METHICONE
POLYGLYCERYL-6 POLYRICINOLEATE
ETHYLHEXYLGLYCERIN
TRIHYDROXYSTEARIN
CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL
ADENOSINE
PINUS SYLVESTRIS LEAF OIL
CITRUS AURANTIFOLIA (LIME) OIL
BHT
EUCALYPTUS GLOBULUS LEAF OIL
CITRUS LIMON (LEMON) PEEL OIL
CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL
ALLANTOIN
GLYCERYL POLYMETHACRYLATE
PROPYLENE GLYCOL
1,2-HEXANEDIOL
PLATINUM POWDER
PALMITOYL TRIPEPTIDE-1
POLYSORBATE 80 - OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DR.JART PREMIUM BEAUTY BALM 03 DEEP
titanium dioxide, zinc oxide, octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49404-141 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.32 mg in 40 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2 mg in 40 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.716 mg in 40 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.8 mg in 40 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) GLYCERIN (UNII: PDC6A3C0OX) TALC (UNII: 7SEV7J4R1U) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) NIACINAMIDE (UNII: 25X51I8RD4) DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) DIPROPYLENE GLYCOL (UNII: E107L85C40) HEXYL LAURATE (UNII: 4CG9F9W01Q) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) DIMETHICONE (UNII: 92RU3N3Y1O) FERRIC OXIDE RED (UNII: 1K09F3G675) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERROSOFERRIC OXIDE (UNII: XM0M87F357) METHICONE (20 CST) (UNII: 6777U11MKT) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) ORANGE OIL (UNII: AKN3KSD11B) ADENOSINE (UNII: K72T3FS567) PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y) LIME OIL (UNII: UZH29XGA8G) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) EUCALYPTUS OIL (UNII: 2R04ONI662) LEMON OIL (UNII: I9GRO824LL) BERGAMOT OIL (UNII: 39W1PKE3JI) ALLANTOIN (UNII: 344S277G0Z) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PLATINUM (UNII: 49DFR088MY) PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49404-141-02 1 in 1 CARTON 09/11/2018 1 NDC:49404-141-01 40 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/11/2018 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(49404-141)
