AHC Intense Contour Balm

Drug Labeling and Warnings

Drug Details [pdf]

AHC INTENSE CONTOUR BALM- titanium dioxide cream 
Carver Korea 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.

----------

AHC Intense Contour Balm

ACTIVE INGREDIENT

ACTIVE INGREDIENT

  Active Ingredients   Purpose 
  Titanium Dioxide   Sunscreen

Use

Helps prevent sunburn

Warning

For external use only

Do not use on damaged or broken skin

Dosage: Small Amount

Administration: apply to a clean skin and massage gently

WATER
CETYL ETHYLHEXANOATE
PROPYLENE GLYCOL
MINERAL OIL
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
TALC
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE
MAGNESIUM SULFATE
SORBITAN SESQUIOLEATE
ZINC STEARATE
BROWN IRON OXIDE
MICROCRYSTALLINE WAX
QUATERNIUM-18
FERROSOFERRIC OXIDE
SILICA DIMETHYL SILYLATE
TRIETHOXYCAPRYLYLSILANE
BUTYLENE GLYCOL
METHYLPARABEN
BUTYLPARABEN
ALLANTOIN
CHLORPHENESIN
PROPYLPARABEN
ULTRAMARINE BLUE
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)
.ALPHA.-TOCOPHEROL ACETATE
MICA
.ALPHA.-BISABOLOL, (+/-)-
CAMELLIA SINENSIS WHOLE
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
SOPHORA FLAVESCENS ROOT
PLATYCODON GRANDIFLORUM ROOT
CENTELLA ASIATICA
POLYGALA TENUIFOLIA ROOT
MELIA AZEDARACH WHOLE
CITRUS PARADISI WHOLE

Beeswax

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

AHC INTENSE CONTOUR BALM 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58930-021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.46 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MINERAL OIL (UNII: T5L8T28FGP)  
TALC (UNII: 7SEV7J4R1U)  
ZINC STEARATE (UNII: H92E6QA4FV)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
ALLANTOIN (UNII: 344S277G0Z)  
MICA (UNII: V8A1AW0880)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58930-021-011 in 1 CARTON07/30/201312/01/2018
130 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC: 58930-021-021 in 1 CARTON07/30/201312/01/2018
250 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/30/201312/01/2018
Labeler - Carver Korea Co.,Ltd. (688442290)
Registrant - Jemian USA Inc. (078822273)
Establishment
NameAddressID/FEIBusiness Operations
Nowcos.Co.,Ltd689914984manufacture(58930-021)

Revised: 5/2019
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.