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.

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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

AHC INTENSE CONTOUR BALM 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58930-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.46 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58930-021-01	1 in 1 CARTON	07/30/2013	12/01/2018
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 58930-021-02	1 in 1 CARTON	07/30/2013	12/01/2018
2		50 mL in 1 TUBE; 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	07/30/2013	12/01/2018

Labeler - Carver Korea Co.,Ltd. (688442290)

Registrant - Jemian USA Inc. (078822273)

Establishment
Name	Address	ID/FEI	Business Operations
Nowcos.Co.,Ltd		689914984	manufacture(58930-021)

Revised: 5/2019

Document Id: 9f6d7732-166f-4acc-83a5-392854b588be

34390-5

Set id: 7ad93576-809e-4c7c-9070-f800cd273097

Version: 2

Effective Time: 20190517