Label: DR.JART PREMIUM BEAUTY BALM 02 MEDIUM DEEP- octinoxate, octisalate cream
- NDC Code(s): 49404-138-01, 49404-138-02
- 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
If you are a consumer or patient please visit this version.
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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
PEG-10 DIMETHICONE
NIACINAMIDE
C12-15 ALKYL BENZOATE
DIPHENYLSILOXY PHENYL TRIMETHICONE
DIPROPYLENE GLYCOL
HEXYL LAURATE
IRON OXIDES(CI 77492)
TALC
DISTEARDIMONIUM HECTORITE
MAGNESIUM SULFATE
DIMETHICONE/VINYL DIMETHICONECROSSPOLYMER
DIMETHICONE
TRIETHOXYCAPRYLYLSILANE
IRON OXIDES(CI 77491)
PHENOXYETHANOL
IRON OXIDES(CI 77499)
METHICONE
POLYGLYCERYL-6 POLYRICINOLEATE
ETHYLHEXYLGLYCERIN
TRIHYDROXYSTEARIN
ADENOSINE
CITRUS AURANTIUM DULCIS (ORANGE) PEELOIL
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
1,2-HEXANEDIOL
PALMITOYL TRIPEPTIDE-5
PLATINUM POWDER
PALMITOYL HEXAPEPTIDE-12
POLYSORBATE 80 - OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DR.JART PREMIUM BEAUTY BALM 02 MEDIUM DEEP
octinoxate, octisalate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49404-138 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.716 mg in 40 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 2 mg in 40 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.8 mg in 40 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 3.18 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 RED (UNII: 1K09F3G675) 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) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) DIMETHICONE (UNII: 92RU3N3Y1O) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) FERROSOFERRIC OXIDE (UNII: XM0M87F357) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) PHENOXYETHANOL (UNII: HIE492ZZ3T) 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) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 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:49404-138-02 1 in 1 CARTON 07/20/2020 1 NDC:49404-138-01 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 01/08/2018 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(49404-138)
