AMOREPACIFIC MOISTURE BOUND TINTED TREATMENT MOISTURIZER NO. 102- octinoxate and titanium dioxide lotion 
AMOREPACIFIC MOISTURE BOUND TINTED TREATMENT MOISTURIZER NO. 104- octinoxate and titanium dioxide lotion 
AMOREPACIFIC MOISTURE BOUND TINTED TREATMENT MOISTURIZER NO. 106- octinoxate and titanium dioxide lotion 
AMOREPACIFIC MOISTURE BOUND TINTED TREATMENT MOISTURIZER NO. 204- octinoxate and titanium dioxide lotion 
AMOREPACIFIC Corporation

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.

----------

AMOREPACIFIC

MOISTURE BOUND

Tinted Treatment Moisturizer

SPF 15

Drug Facts

ACTIVE INGREDIENTS W/W

ETHYLHEXYL METHOXYCINNAMATE 5%
TITANIUM DIOXIDE 2.1%

PURPOSE

Sunscreen

USES

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

For external use only

When using this product

  • keep out of eyes.
  • rinse with water to remove.

Do not use on

  • damaged or broken skin.

Stop use and ask a doctor if

  • rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 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.

STORAGE CONDITION

  • Stored sunscreen at room temperature, between 50 and 86 degrees F(10 and 30 degrees C).

INACTIVE INGREDIENTS

PHYLLOSTACHIS BAMBUSOIDES JUICE, METHYL TRIMETHICONE, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, BUTYLENE GLYCOL, GLYCERIN, TITANIUM DIOXIDE (CI 77891), C12-15 ALKYL BENZOATE, BIS-HYDROXYETHOXYPROPYL DIMETHICONE, LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, ALCOHOL, POLYMETHYL METHACRYLATE, DISTEARDIMONIUM HECTORITE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, TRIHYDROXYSTEARIN, PEG-10 DIMETHICONE, PANAX GINSENG ROOT EXTRACT, SODIUM CHLORIDE, SORBITAN ISOSTEARATE, IRON OXIDES (CI 77 492), ALUMINUM STEARATE, PHENOXYETHANOL, POLYHYDROXYSTEARIC ACID, FRAGRANCE / PARFUM, IRON OXIDES (CI 77491), ALUMINA, LAMINARIA OCHROLEUCA EXTRACT, TALC, ALUMINUM HYDROXIDE, TRIETHOXYCAPRYLYLSILANE, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, IRON OXIDES (CI 77499), ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, WATER / AQUA / EAU, TRICHOLOMA MATSUTAKE EXTRACT, KAEMPFEROL, ACRYLATES/TRIDECYL ACRYLATE/TRIETHOXYSILYLPROPYL METHACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, PROPYLENE GLYCOL, ZINC GLUCONATE, MAGNESIUM ASPARTATE, HYDROGENATED LECITHIN, PEG-5 RAPESEED STEROL, HYDROLYZED GINSENG SAPONINS (ENZYME-TREATED RED GINSENG SAPONINS), CALCIUM GLUCONATE, COPPER GLUCONATE

Questions?

For US customers support@us.amorepacific.com

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - 102

AMOREPACIFIC

102

MOISTURE BOUND
Tinted Treatment Moisturizer
SPF 15
Sunscreen

1.6 FL. OZ./ 50 ml e

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - 102

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - 104

AMOREPACIFIC

104

MOISTURE BOUND
Tinted Treatment Moisturizer
SPF 15
Sunscreen

1.6 FL. OZ./ 50 ml e

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - 104

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - 106

AMOREPACIFIC

106

MOISTURE BOUND
Tinted Treatment Moisturizer
SPF 15
Sunscreen

1.6 FL. OZ./ 50 ml e

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - 106

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - 204

AMOREPACIFIC

204

MOISTURE BOUND
Tinted Treatment Moisturizer
SPF 15
Sunscreen

1.6 FL. OZ./ 50 ml e

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton - 204
AMOREPACIFIC MOISTURE BOUND TINTED TREATMENT MOISTURIZER  NO. 102
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE21 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ALCOHOL (UNII: 3K9958V90M)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)  
TALC (UNII: 7SEV7J4R1U)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GINGER (UNII: C5529G5JPQ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
COPPER GLUCONATE (UNII: RV823G6G67)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-501-0150 mL in 1 TUBE; Type 0: Not a Combination Product06/01/201108/31/2019
2NDC:43419-501-111 mL in 1 POUCH; Type 0: Not a Combination Product06/01/201109/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201108/31/2019
AMOREPACIFIC MOISTURE BOUND TINTED TREATMENT MOISTURIZER  NO. 104
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-502
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE21 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ALCOHOL (UNII: 3K9958V90M)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)  
TALC (UNII: 7SEV7J4R1U)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GINGER (UNII: C5529G5JPQ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
COPPER GLUCONATE (UNII: RV823G6G67)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-502-0150 mL in 1 TUBE; Type 0: Not a Combination Product06/01/201108/31/2019
2NDC:43419-502-111 mL in 1 POUCH; Type 0: Not a Combination Product06/01/201109/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201108/31/2019
AMOREPACIFIC MOISTURE BOUND TINTED TREATMENT MOISTURIZER  NO. 106
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-503
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE21 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ALCOHOL (UNII: 3K9958V90M)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)  
TALC (UNII: 7SEV7J4R1U)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GINGER (UNII: C5529G5JPQ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
COPPER GLUCONATE (UNII: RV823G6G67)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-503-0150 mL in 1 TUBE; Type 0: Not a Combination Product06/01/201108/31/2019
2NDC:43419-503-111 mL in 1 POUCH; Type 0: Not a Combination Product06/01/201109/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201108/31/2019
AMOREPACIFIC MOISTURE BOUND TINTED TREATMENT MOISTURIZER  NO. 204
octinoxate and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43419-504
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE21 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
PHYLLOSTACHYS RETICULATA RESIN (UNII: KX390ME4SP)  
METHYL TRIMETHICONE (UNII: S73ZQI0GXM)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
ALCOHOL (UNII: 3K9958V90M)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)  
TALC (UNII: 7SEV7J4R1U)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GINGER (UNII: C5529G5JPQ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
COPPER GLUCONATE (UNII: RV823G6G67)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43419-504-0150 mL in 1 TUBE; Type 0: Not a Combination Product06/01/201108/31/2019
2NDC:43419-504-111 mL in 1 POUCH; Type 0: Not a Combination Product06/01/201109/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201108/31/2019
Labeler - AMOREPACIFIC Corporation (631035289)
Establishment
NameAddressID/FEIBusiness Operations
AMOREPACIFIC Corporation694894112manufacture(43419-501, 43419-502, 43419-503, 43419-504)

Revised: 9/2019
Document Id: 91d270bf-17be-ec57-e053-2995a90aa9c0
Set id: fb367cf4-641a-4d9b-933d-b45838ce3dc9
Version: 5
Effective Time: 20190905
 
AMOREPACIFIC Corporation