DR.JART PREMIUM BEAUTY BALM MEDIUM-TAN- zinc oxide, titanium dioxide, octinoxate, octisalate cream 
Have & Be Co., Ltd.

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.

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DR.JART PREMIUM BEAUTY BALM MEDIUM-TAN

OCTINOXATE 6.8%
OCTISALATE 4.5%
TITANIUM DIOXIDE 4.8%
ZINC OXIDE 5.0%


Sunscreen

Helps prevent sunburn

For sunscreen use:
■ 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 a.m. – 2 p.m.
– wear long-sleeved shirts, pants, hats and sunglasses
■ children under 6 months of age: ask a doctor

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 using and ask a doctor if rash occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

WATER, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, GLYCERIN, TALC, PEG-10 DIMETHICONE, IRON OXIDES(CI 77492), C12-15 ALKYL BENZOATE, HEXYL LAURATE, DIPHENYLSILOXY PHENYL TRIMETHICONE, NIACINAMIDE, DIPROPYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, TITANIUM DIOXIDE(CI 77891), MAGNESIUM SULFATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE, IRON OXIDES(CI 77491), TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, IRON OXIDES(CI 77499), METHICONE, POLYGLYCERYL-6 POLYRICINOLEATE, TRIHYDROXYSTEARIN, ETHYLHEXYLGLYCERIN, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, ADENOSINE, CITRUS AURANTIFOLIA (LIME) OIL, PINUS SYLVESTRIS LEAF OIL, BHT, EUCALYPTUS GLOBULUS LEAF OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, CITRUS LIMON (LEMON) PEEL OIL, TOCOPHEROL, ALLANTOIN, GLYCERYL POLYMETHACRYLATE, PROPYLENE GLYCOL, 1,2-HEXANEDIOL, POLYSORBATE 80, PLATINUM POWDER, PALMITOYL TRIPEPTIDE-1

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

Principal Display Panel

DR.JART PREMIUM BEAUTY BALM MEDIUM-TAN 
zinc oxide, titanium dioxide, octinoxate, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49404-303
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE48 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE68 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE45 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
TALC (UNII: 7SEV7J4R1U)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ALLANTOIN (UNII: 344S277G0Z)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PLATINUM (UNII: 49DFR088MY)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
METHICONE (20 CST) (UNII: 6777U11MKT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ADENOSINE (UNII: K72T3FS567)  
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)  
LIME OIL, COLD PRESSED (UNII: UZH29XGA8G)  
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49404-303-011 in 1 CARTON08/11/2023
140 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02008/11/2023
Labeler - Have & Be Co., Ltd. (690400408)
Registrant - Estee Lauder Companies Inc. (790802086)
Establishment
NameAddressID/FEIBusiness Operations
HK Kolmar Canada, Inc243501959manufacture(49404-303)

Revised: 8/2023
Document Id: 02a8b96b-790c-9c21-e063-6294a90aec38
Set id: 02a8bab8-ca5d-6b65-e063-6294a90abb07
Version: 1
Effective Time: 20230811
 
Have & Be Co., Ltd.