A.H.C.COMPLETE CHOICE Moisture Cream

Drug Labeling and Warnings

Drug Details [pdf]

A.H.C. COMPLETE CHOICE COLOR CHANGE CREAM- ethylhexyl methoxycinnamate, titanuim dioxide, ethylhexyl salicytlate, zinc oxide 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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A.H.C.
COMPLETE CHOICE Moisture Cream

ACTIVE INGREDIENT

ACTIVE INGREDIENT

• Active Ingredients: Purpose
• Ethylhexyl Methoxycinnamate 7.5%: Sunscreen
• Titanium Dioxide 6.11%: Sunscreen
• Ethylhexyl Salicylate 5%: Sunscreen
• Zinc Oxide 4.9%: Sunscreen

Uses

Helps prevent sunburn 

Warning

For external use only

do not use on damaged or broken skin

Apply small amount to a clean skin and massage gently with fingertips.

Dosage: Small Amount

Administration: apply to a clean skin and massage gently

Inactive Ingredients

WATER
DIPHENYLSILOXY PHENYL TRIMETHICONE
1,3-BUTYLENE GLYCOL
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
BUTYLENE GLYCOL DICAPRATE
METHYL METHACRYLATE
SODIUM CHLORIDE
TRIBEHENIN
MICA
GLYCERIN
SORBITAN ISOSTEARATE
PENTYLENE GLYCOL
DISTEARDIMONIUM HECTORITE
DIMETHICONE
BROWN IRON OXIDE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
PEG-10 DIMETHICONE (600 CST)
PHENOXYETHANOL
ALUMINUM HYDROXIDE
STEARIC ACID
GLYCERYL BEHENATE
POLYGLYCERYL-6 DISTEARATE
DIMETHICONE
POLYESTER-10
TRIMETHOXYCAPRYLYLSILANE
SILICA DIMETHYL SILYLATE
MONOSODIUM ETHYLENEDIAMINETETRAACETATE
ETHYLHEXYLGLYCERIN
ALPHA-TOCOPHEROL ACETATE
CAMELLIA SINENSIS WHOLE
ORYZA SATIVA WHOLE
TARAXACUM OFFICINALE ROOT
ADANSONIA DIGITATA FRUIT PULP
2-ETHYL-1,6-HEXANEDIOL
SELENICEREUS GRANDIFLORUS FLOWER
PRUNUS MUME FRUIT
SOY PROTEIN
XANTHAN GUM
METHYLPARABEN
HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW)
VIGNA RADIATA WHOLE
MORUS AUSTRALIS WOOD
ETHYLPARABEN
GENTIANA LUTEA ROOT
ACHILLEA MILLEFOLIUM
ARTEMISIA ABSINTHIUM WHOLE
ARNICA MONTANA FLOWER
BUTYLPARABEN
BIOTINOYL TRIPEPTIDE-1
ISOBUTYLPARABEN
PROPYLPARABEN
POTASSIUM SORBATE

FRAGNANCE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

A.H.C. COMPLETE CHOICE COLOR CHANGE CREAM 
ethylhexyl methoxycinnamate, titanuim dioxide, ethylhexyl salicytlate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58930-016
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.62 g  in 35 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.14 g  in 35 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.75 g  in 35 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.715 g  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MICA (UNII: V8A1AW0880)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58930-016-02	1 in 1 CARTON	07/05/2013	12/01/2018
1	NDC: 58930-016-01	35 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	07/05/2013	12/01/2018

Labeler - Carver Korea Co.,Ltd (688442290)

Registrant - Jemian USA Inc. (078822273)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(58930-016)

Revised: 5/2019

Document Id: c6637512-81ed-45b4-84a2-b28787e9d4ba

34390-5

Set id: f615733a-681b-4634-b9b8-b3dac070c189

Version: 3

Effective Time: 20190516