aqua fit cushion

Drug Labeling and Warnings

Drug Details [pdf]

AQUA FIT CUSHION C11- octinoxate, titanium dioxide, and zinc oxide lotion 
AQUA FIT CUSHION C13- octinoxate, titanium dioxide, and zinc oxide lotion 
AQUA FIT CUSHION C21- octinoxate, titanium dioxide, and zinc oxide lotion 
AQUA FIT CUSHION N21- octinoxate, titanium dioxide, and zinc oxide lotion 
AQUA FIT CUSHION W21- octinoxate, titanium dioxide, and zinc oxide lotion 
AQUA FIT CUSHION N23- octinoxate, titanium dioxide, and zinc oxide lotion 
AQUA FIT CUSHION W23- octinoxate, titanium dioxide, and zinc oxide lotion 
AQUA FIT CUSHION N27- octinoxate, titanium dioxide, and zinc oxide lotion 
AQUA FIT CUSHION N31- octinoxate, titanium dioxide, and zinc oxide lotion 
AQUA FIT CUSHION W33- octinoxate, titanium dioxide, and zinc oxide lotion 
AQUA FIT CUSHION W34- octinoxate, titanium dioxide, and zinc oxide lotion 
AQUA FIT CUSHION W35- octinoxate, titanium dioxide, and zinc oxide lotion 
AQUA FIT CUSHION W37- octinoxate, titanium dioxide, and zinc oxide lotion 
AQUA FIT CUSHION C43- octinoxate, titanium dioxide, and zinc oxide lotion 
Innisfree 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.

----------

aqua fit cushion

Drug Facts

Active ingredientsPurpose
Octinoxate 7%Sunscreen
Titanium Dioxide 1.66%Sunscreen
Zinc Oxide 1.96%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

  • Do not use on damaged or broken skin

  • When using this product keep out of eyes. Rinse with water to remove.

  • 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

Inactive ingredients

WATER, CYCLOPENTASILOXANE, PHENYL TRIMETHICONE, TITANIUM DIOXIDE (CI 77891), GLYCERIN, PEG-10 DIMETHICONE, CYCLOHEXASILOXANE, POLYMETHYL METHACRYLATE, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, DIMETHICONE, PROPANEDIOL, BORON NITRIDE, LAURYL PEG-8 DIMETHICONE, NIACINAMIDE, DISTEARDIMONIUM HECTORITE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, POLYSILICONE-11, POLYSORBATE 40, SODIUM CHLORIDE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, IRON OXIDES (CI 77492), ALUMINUM HYDROXIDE, CAPRYLYL GLYCOL, FRAGRANCE, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, BUTYLENE GLYCOL, IRON OXIDES (CI 77491), ETHYLHEXYLGLYCERIN, ALCOHOL, PHENOXYETHANOL, DISODIUM EDTA, ADENOSINE, IRON OXIDES (CI 77499), MANNAN, SODIUM HYALURONATE, CAMELLIA SINENSIS LEAF EXTRACT, CITRIC ACID, MINERAL SALTS, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT EXTRACT, CITRUS AURANTIUM DULCIS (ORANGE) FRUIT EXTRACT, CITRUS PARADISI (GRAPEFRUIT) FRUIT EXTRACT, CITRUS TANGERINA (TANGERINE) EXTRACT, LACTIC ACID, ASCORBIC ACID, CAMELLIA JAPONICA LEAF EXTRACT, CITRUS UNSHIU PEEL EXTRACT, OPUNTIA COCCINELLIFERA FRUIT EXTRACT, ORCHID EXTRACT

Other information

  • protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - C11 Cool ivory

innisfree

AQUA-FIT CUSHION
broadspectrum SPF 40

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - C11 Cool ivory

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - C13 Light beige

innisfree

AQUA-FIT CUSHION
broadspectrum SPF 40

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - C13 Light beige

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - C21 Pink beige

innisfree

AQUA-FIT CUSHION
broadspectrum SPF 40

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - C21 Pink beige

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N21 Natural beige

innisfree

AQUA-FIT CUSHION
broadspectrum SPF 40

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N21 Natural beige

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W21 Warm beige

innisfree

AQUA-FIT CUSHION
broadspectrum SPF 40

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W21 Warm beige

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N23 True beige

innisfree

AQUA-FIT CUSHION
broadspectrum SPF 40

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N23 True beige

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W23 Golden beige

innisfree

AQUA-FIT CUSHION
broadspectrum SPF 40

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W23 Golden beige

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N27 Sand

innisfree

AQUA-FIT CUSHION
broadspectrum SPF 40

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N27 Sand

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N31 Walnut

innisfree

AQUA-FIT CUSHION
broadspectrum SPF 40

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - N31 Walnut

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W33 Chestnut

innisfree

AQUA-FIT CUSHION
broadspectrum SPF 40

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W33 Chestnut

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W34 Golden caramel

innisfree

AQUA-FIT CUSHION
broadspectrum SPF 40

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W34 Golden caramel

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W35 Golden cinnamon

innisfree

AQUA-FIT CUSHION
broadspectrum SPF 40

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W35 Golden cinnamon

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W37 Golden tan

innisfree

AQUA-FIT CUSHION
broadspectrum SPF 40

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - W37 Golden tan

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - C43 Chocolate

innisfree

AQUA-FIT CUSHION
broadspectrum SPF 40

NET WT. 0.49 OZ./14g

PRINCIPAL DISPLAY PANEL - 14 g Container Carton - C43 Chocolate
AQUA FIT CUSHION C11 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-027
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.66 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.96 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPANEDIOL (UNII: 5965N8W85T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
YEAST MANNAN (UNII: 91R887N59P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
TANGERINE PEEL (UNII: JU3D414057)  
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71220-027-011 in 1 CARTON06/23/201710/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/201710/14/2019
AQUA FIT CUSHION C13 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-028
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.66 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.96 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PROPANEDIOL (UNII: 5965N8W85T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ADENOSINE (UNII: K72T3FS567)  
YEAST MANNAN (UNII: 91R887N59P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
TANGERINE PEEL (UNII: JU3D414057)  
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71220-028-011 in 1 CARTON06/23/201710/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/201710/14/2019
AQUA FIT CUSHION C21 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-029
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.66 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.96 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PROPANEDIOL (UNII: 5965N8W85T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
YEAST MANNAN (UNII: 91R887N59P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
TANGERINE PEEL (UNII: JU3D414057)  
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71220-029-011 in 1 CARTON06/23/201710/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/201710/14/2019
AQUA FIT CUSHION N21 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.66 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.96 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPANEDIOL (UNII: 5965N8W85T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
YEAST MANNAN (UNII: 91R887N59P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
TANGERINE PEEL (UNII: JU3D414057)  
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71220-030-011 in 1 CARTON06/23/201710/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/201710/14/2019
AQUA FIT CUSHION W21 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.66 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.96 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPANEDIOL (UNII: 5965N8W85T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
YEAST MANNAN (UNII: 91R887N59P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
TANGERINE PEEL (UNII: JU3D414057)  
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71220-031-011 in 1 CARTON06/23/201710/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/201710/14/2019
AQUA FIT CUSHION N23 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-032
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.66 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.96 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPANEDIOL (UNII: 5965N8W85T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
YEAST MANNAN (UNII: 91R887N59P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
TANGERINE PEEL (UNII: JU3D414057)  
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71220-032-011 in 1 CARTON06/23/201710/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/201710/14/2019
AQUA FIT CUSHION W23 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.66 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.96 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPANEDIOL (UNII: 5965N8W85T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
NIACINAMIDE (UNII: 25X51I8RD4)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
YEAST MANNAN (UNII: 91R887N59P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
TANGERINE PEEL (UNII: JU3D414057)  
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71220-033-011 in 1 CARTON06/23/201710/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/201710/14/2019
AQUA FIT CUSHION N27 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.66 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.96 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
PROPANEDIOL (UNII: 5965N8W85T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
YEAST MANNAN (UNII: 91R887N59P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
TANGERINE PEEL (UNII: JU3D414057)  
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71220-034-011 in 1 CARTON06/23/201710/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/201710/14/2019
AQUA FIT CUSHION N31 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.66 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.96 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPANEDIOL (UNII: 5965N8W85T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
NIACINAMIDE (UNII: 25X51I8RD4)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ALCOHOL (UNII: 3K9958V90M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
YEAST MANNAN (UNII: 91R887N59P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
TANGERINE PEEL (UNII: JU3D414057)  
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71220-035-011 in 1 CARTON06/23/201710/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/201710/14/2019
AQUA FIT CUSHION W33 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-036
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.66 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.96 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPANEDIOL (UNII: 5965N8W85T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
NIACINAMIDE (UNII: 25X51I8RD4)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
YEAST MANNAN (UNII: 91R887N59P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
TANGERINE PEEL (UNII: JU3D414057)  
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71220-036-011 in 1 CARTON06/23/201710/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/201710/14/2019
AQUA FIT CUSHION W34 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-037
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.66 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.96 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PROPANEDIOL (UNII: 5965N8W85T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
YEAST MANNAN (UNII: 91R887N59P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
TANGERINE PEEL (UNII: JU3D414057)  
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71220-037-011 in 1 CARTON06/23/201710/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/201710/14/2019
AQUA FIT CUSHION W35 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.66 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.96 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PROPANEDIOL (UNII: 5965N8W85T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
YEAST MANNAN (UNII: 91R887N59P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
TANGERINE PEEL (UNII: JU3D414057)  
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71220-038-011 in 1 CARTON06/23/201710/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/201710/14/2019
AQUA FIT CUSHION W37 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-039
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.66 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.96 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PROPANEDIOL (UNII: 5965N8W85T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
YEAST MANNAN (UNII: 91R887N59P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
TANGERINE PEEL (UNII: JU3D414057)  
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71220-039-011 in 1 CARTON06/23/201710/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/201710/14/2019
AQUA FIT CUSHION C43 
octinoxate, titanium dioxide, and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71220-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 14 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.66 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.96 g  in 14 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PROPANEDIOL (UNII: 5965N8W85T)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
NIACINAMIDE (UNII: 25X51I8RD4)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
POLYSORBATE 40 (UNII: STI11B5A2X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALCOHOL (UNII: 3K9958V90M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ADENOSINE (UNII: K72T3FS567)  
YEAST MANNAN (UNII: 91R887N59P)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
ORANGE (UNII: 5EVU04N5QU)  
GRAPEFRUIT (UNII: O82C39RR8C)  
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
TANGERINE PEEL (UNII: JU3D414057)  
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71220-040-011 in 1 CARTON06/23/201710/14/2019
114 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/23/201710/14/2019
Labeler - Innisfree Corporation (557822425)
Establishment
NameAddressID/FEIBusiness Operations
COSVISION557789645manufacture(71220-027, 71220-028, 71220-029, 71220-030, 71220-031, 71220-032, 71220-033, 71220-034, 71220-035, 71220-036, 71220-037, 71220-038, 71220-039, 71220-040)

Revised: 10/2019
 

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