RADIANCE SUPERBE DAY CREAM NUDE- ensulizole, octocrylene, titanium dioxide, zinc oxide cream 
RADIANCE SUPERBE DAY CREAM NEUTRAL BRONZE- ensulizole, octocrylene, titanium dioxide, zinc oxide cream 
RADIANCE SUPERBE DAY CREAM NEUTRAL LIGHT- ensulizole, octocrylene, titanium dioxide, zinc oxide cream 
RADIANCE SUPERBE DAY CREAM TRANSLUCENT- ensulizole, octocrylene, titanium dioxide, zinc oxide cream 
RADIANCE SUPERBE DAY CREAM NEUTRAL MEDIUM- ensulizole, octocrylene, titanium dioxide, zinc oxide cream 
RADIANCE SUPERBE DAY CREAM NEUTRAL CARAMEL- ensulizole, octocrylene, titanium dioxide, zinc oxide cream 
RADIANCE SUPERBE DAY CREAM NEUTRAL TAN- ensulizole, octocrylene, titanium dioxide, zinc oxide cream 
Haute Custom Beauty

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.

----------

Radiance Superbe Day Cream (Translucent and 6 tones)

Active Ingredients......sunscreen

Octocrylene 6%.........Sunscreen

Titanium dioxide 5%.........Sunscreen

Zinc oxide 5%.........Sunscreen

Ensulizole 4%..........Sunscreen

Inactive Ingredients

AQUA (WATER), PROPANEDIOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, SODIUM ACRYLATES COPOLYMER, COPERNICIA CERIFERA WAX, ORYZA SATIVA WAX, CENTELLA ASIATICA (HYDROCOTYL) LEAF EXTRACT, HYDROLIZED SILK, LECITHIN, TOCOPHERYL ACETATE, XANTHAN GUM, POLYHYDROXYSTEARIC ACID, ALUMINA, STEARIC ACID, ROYAL JELLY EXTRACT, GLYCERYL LINOLEATE, GLYCERYL LINOLENATE, PANTHENOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, PHENOXYETHANOL, GLYCERIN, CAPRYLYL GLYCOL, SODIUM HYDROXIDE, MALUS DOMESTICA FRUIT CELL CULTURE EXTRACT, ARTEMIA EXTRACT, PLANKTON EXTRACT, ALGAE EXTRACT, PARFUM (FRAGANCE), PHYTOSTEROLS, OLEA EUROPAEA (OLIVE) FRUIT OIL, SQUALANE, HYDROLYZED PEA PROTEIN, BUTYROSPERMUM PARKII (SHEA) BUTTER, CERAMIDE NP, CERAMIDE AP, CERAMIDE EOP, PHYTOSPHINGOSINE, CHOLESTEROL, SODIUM LAUROYL LACTYLATE, CARBOMER, DIISOPROPYL ADIPATE, ACRYLIC ACID/ACRYLAMIDOMETHYL PROPANE SULFONIC ACID COPOLYMER, DIMETHYLMETHOXY CHROMANOL, GLYCERYL CAPRILATE, PHOSPHOLIPIDS, CARAMEL, CI 77891, CI 77492, CI 77491 , CI 77499 , CINNAMYL ALCOHOL, EUGENOL, HEXYL CINNAMAL, LINALOOL, d-LIMONENE, CITRONELLOL, BENZYL SALICYLATE.

Uses

helps prevent sunburn * higher SPF gives more sunburn protection * 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 or irratation develos and lasts.

You may report effects to FDA at 1-800-FDA-1088.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For suncreen use: *apply liberally 15 minutes before sun exposure and as needed * reapply at least every 2 hours and as needed or after towel drying, swimming, or perspiring. *. use 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 value of SPF 15 or higher and other sun protection measures including:

* limit time in th esun, especially from 10 a.m. - 2 p.m.

* wear long-sleeve shirts, pants, hats and sunglasses

*children under 6 months of age: Ask a doctor

Other information

Other information * protect this product from excessive heat and direct sun. * Sun alert: limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Description

RADIANCE SUPERBE DAY CREAM

BROAD SPECTRUM SPF 35

OIL-FREE SUNSCREEN

A latest generation Triple Age Management Sunscreen with an immediate ultra-sheer complexion perfecting finish availalbe in 6 ultra-sheer shades + translucent, leaving skin with a radiant, healthy glow. Oil free, for all skin types, including sensitive skin.

Haute Custom Beauty SLU

Passeig de Gracia 41

08047 Barcelona

Haute Custom Beauty INC

Austin, TX 78703 USA

PRODUCT OF SPAIN

www.hautecustombeauty.com

Airplane image OK

Gluten Free

No: parabens, sulphates, mineral oil, silicons, phthalates, PEGS, methysilothazzolinone, petroleum derivatives

AB

Radiance Superbe Day Cream Nude
72414-001

principal display panel box nude

b

c

Radiance Superbe Day Cream Neutral Light
72414-002

Neutral Light

Box2

box2 drug facts

Radiance Superbe Day Cream Neutral Medium
72414-003

Neutral Medium

Radiance Superbe Day Cream Neutral Caramel
72414-004

radiance superbe box

Principal Display Panel

Principal Display Panel

Radiance Superbe Day Cream Neutral Tan
72414-005

Principal Display Panel

Box2

Radiance Superbe Day Cream Neutral Bronze
72414-006

Principal Display Panel

RADIANCE SUPERBE DAY CREAM NUDE 
ensulizole, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72414-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CERAMIDE AP (UNII: F1X8L2B00J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
GLYCERYL LINOLENATE (UNII: SGB6X4G86K)  
PEA PROTEIN (UNII: 7Q50F46595)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
CERAMIDE NP (UNII: 4370DF050B)  
CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)  
ROYAL JELLY (UNII: L497I37F0C)  
PANTHENOL (UNII: WV9CM0O67Z)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
PROPANEDIOL (UNII: 5965N8W85T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
SILK, ENZYME HYDROLYZED (1000 MW) (UNII: 960MDR3Z07)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)  
SODIUM 2-ACRYLAMIDO-2-METHYL-1-PROPANE SULFONATE/SODIUM ACRYLATE/N-ISOPROPYLACRYLAMIDE/TRIMETHYL(3-METHACRYLAMIDOPROPYL)AMMONIUM CHLORIDE COPOLYMER (UNII: R9E4IU0HDO)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SQUALANE (UNII: GW89575KF9)  
SHEA BUTTER (UNII: K49155WL9Y)  
CERAMIDE EOS (UNII: CR0J8RN66K)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
EUGENOL (UNII: 3T8H1794QW)  
HEXYL CINNAMATE (UNII: 532UJ0Y6RI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72414-001-5050 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/28/2021
2NDC:72414-001-1515 g in 1 APPLICATOR; Type 0: Not a Combination Product12/28/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/28/202112/28/2021
RADIANCE SUPERBE DAY CREAM NEUTRAL BRONZE 
ensulizole, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72414-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CERAMIDE AP (UNII: F1X8L2B00J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
GLYCERYL LINOLENATE (UNII: SGB6X4G86K)  
PEA PROTEIN (UNII: 7Q50F46595)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
CERAMIDE NP (UNII: 4370DF050B)  
CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)  
ROYAL JELLY (UNII: L497I37F0C)  
PANTHENOL (UNII: WV9CM0O67Z)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
PROPANEDIOL (UNII: 5965N8W85T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
SILK, ENZYME HYDROLYZED (1000 MW) (UNII: 960MDR3Z07)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)  
SODIUM 2-ACRYLAMIDO-2-METHYL-1-PROPANE SULFONATE/SODIUM ACRYLATE/N-ISOPROPYLACRYLAMIDE/TRIMETHYL(3-METHACRYLAMIDOPROPYL)AMMONIUM CHLORIDE COPOLYMER (UNII: R9E4IU0HDO)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SQUALANE (UNII: GW89575KF9)  
SHEA BUTTER (UNII: K49155WL9Y)  
CERAMIDE EOS (UNII: CR0J8RN66K)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
EUGENOL (UNII: 3T8H1794QW)  
HEXYL CINNAMATE (UNII: 532UJ0Y6RI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72414-006-5050 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2022
2NDC:72414-006-1515 g in 1 APPLICATOR; Type 0: Not a Combination Product07/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2022
RADIANCE SUPERBE DAY CREAM NEUTRAL LIGHT 
ensulizole, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72414-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CERAMIDE AP (UNII: F1X8L2B00J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
GLYCERYL LINOLENATE (UNII: SGB6X4G86K)  
PEA PROTEIN (UNII: 7Q50F46595)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
CERAMIDE NP (UNII: 4370DF050B)  
CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)  
ROYAL JELLY (UNII: L497I37F0C)  
PANTHENOL (UNII: WV9CM0O67Z)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
PROPANEDIOL (UNII: 5965N8W85T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
SILK, ENZYME HYDROLYZED (1000 MW) (UNII: 960MDR3Z07)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)  
SODIUM 2-ACRYLAMIDO-2-METHYL-1-PROPANE SULFONATE/SODIUM ACRYLATE/N-ISOPROPYLACRYLAMIDE/TRIMETHYL(3-METHACRYLAMIDOPROPYL)AMMONIUM CHLORIDE COPOLYMER (UNII: R9E4IU0HDO)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SQUALANE (UNII: GW89575KF9)  
SHEA BUTTER (UNII: K49155WL9Y)  
CERAMIDE EOS (UNII: CR0J8RN66K)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
EUGENOL (UNII: 3T8H1794QW)  
HEXYL CINNAMATE (UNII: 532UJ0Y6RI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72414-002-5050 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2022
2NDC:72414-002-1515 g in 1 APPLICATOR; Type 0: Not a Combination Product07/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/28/2021
RADIANCE SUPERBE DAY CREAM TRANSLUCENT 
ensulizole, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72414-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CERAMIDE AP (UNII: F1X8L2B00J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
GLYCERYL LINOLENATE (UNII: SGB6X4G86K)  
PEA PROTEIN (UNII: 7Q50F46595)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
CERAMIDE NP (UNII: 4370DF050B)  
CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)  
ROYAL JELLY (UNII: L497I37F0C)  
PANTHENOL (UNII: WV9CM0O67Z)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
PROPANEDIOL (UNII: 5965N8W85T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
SILK, ENZYME HYDROLYZED (1000 MW) (UNII: 960MDR3Z07)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM 2-ACRYLAMIDO-2-METHYL-1-PROPANE SULFONATE/SODIUM ACRYLATE/N-ISOPROPYLACRYLAMIDE/TRIMETHYL(3-METHACRYLAMIDOPROPYL)AMMONIUM CHLORIDE COPOLYMER (UNII: R9E4IU0HDO)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
CERAMIDE EOS (UNII: CR0J8RN66K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SQUALANE (UNII: GW89575KF9)  
SHEA BUTTER (UNII: K49155WL9Y)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
EUGENOL (UNII: 3T8H1794QW)  
HEXYL CINNAMATE (UNII: 532UJ0Y6RI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72414-000-5050 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2022
2NDC:72414-000-1515 g in 1 APPLICATOR; Type 0: Not a Combination Product07/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2022
RADIANCE SUPERBE DAY CREAM NEUTRAL MEDIUM 
ensulizole, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72414-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CERAMIDE AP (UNII: F1X8L2B00J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
GLYCERYL LINOLENATE (UNII: SGB6X4G86K)  
PEA PROTEIN (UNII: 7Q50F46595)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
CERAMIDE NP (UNII: 4370DF050B)  
CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)  
ROYAL JELLY (UNII: L497I37F0C)  
PANTHENOL (UNII: WV9CM0O67Z)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
PROPANEDIOL (UNII: 5965N8W85T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
SILK, ENZYME HYDROLYZED (1000 MW) (UNII: 960MDR3Z07)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)  
SODIUM 2-ACRYLAMIDO-2-METHYL-1-PROPANE SULFONATE/SODIUM ACRYLATE/N-ISOPROPYLACRYLAMIDE/TRIMETHYL(3-METHACRYLAMIDOPROPYL)AMMONIUM CHLORIDE COPOLYMER (UNII: R9E4IU0HDO)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SQUALANE (UNII: GW89575KF9)  
SHEA BUTTER (UNII: K49155WL9Y)  
CERAMIDE EOS (UNII: CR0J8RN66K)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
EUGENOL (UNII: 3T8H1794QW)  
HEXYL CINNAMATE (UNII: 532UJ0Y6RI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72414-003-5050 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2022
2NDC:72414-003-1515 g in 1 APPLICATOR; Type 0: Not a Combination Product07/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2022
RADIANCE SUPERBE DAY CREAM NEUTRAL CARAMEL 
ensulizole, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72414-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CERAMIDE AP (UNII: F1X8L2B00J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
GLYCERYL LINOLENATE (UNII: SGB6X4G86K)  
PEA PROTEIN (UNII: 7Q50F46595)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
CERAMIDE NP (UNII: 4370DF050B)  
CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)  
ROYAL JELLY (UNII: L497I37F0C)  
PANTHENOL (UNII: WV9CM0O67Z)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
PROPANEDIOL (UNII: 5965N8W85T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
SILK, ENZYME HYDROLYZED (1000 MW) (UNII: 960MDR3Z07)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)  
SODIUM 2-ACRYLAMIDO-2-METHYL-1-PROPANE SULFONATE/SODIUM ACRYLATE/N-ISOPROPYLACRYLAMIDE/TRIMETHYL(3-METHACRYLAMIDOPROPYL)AMMONIUM CHLORIDE COPOLYMER (UNII: R9E4IU0HDO)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SQUALANE (UNII: GW89575KF9)  
SHEA BUTTER (UNII: K49155WL9Y)  
CERAMIDE EOS (UNII: CR0J8RN66K)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
EUGENOL (UNII: 3T8H1794QW)  
HEXYL CINNAMATE (UNII: 532UJ0Y6RI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72414-004-5050 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2022
2NDC:72414-004-1515 g in 1 APPLICATOR; Type 0: Not a Combination Product07/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2022
RADIANCE SUPERBE DAY CREAM NEUTRAL TAN 
ensulizole, octocrylene, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72414-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CERAMIDE AP (UNII: F1X8L2B00J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
GLYCERYL LINOLENATE (UNII: SGB6X4G86K)  
PEA PROTEIN (UNII: 7Q50F46595)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
CERAMIDE NP (UNII: 4370DF050B)  
CINNAMYL ALCOHOL (UNII: SS8YOP444F)  
BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
MALUS DOMESTICA WHOLE (UNII: 04W636S1V3)  
ROYAL JELLY (UNII: L497I37F0C)  
PANTHENOL (UNII: WV9CM0O67Z)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
PROPANEDIOL (UNII: 5965N8W85T)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
SILK, ENZYME HYDROLYZED (1000 MW) (UNII: 960MDR3Z07)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL LINOLEATE (UNII: 7B8K5VPO5S)  
SODIUM 2-ACRYLAMIDO-2-METHYL-1-PROPANE SULFONATE/SODIUM ACRYLATE/N-ISOPROPYLACRYLAMIDE/TRIMETHYL(3-METHACRYLAMIDOPROPYL)AMMONIUM CHLORIDE COPOLYMER (UNII: R9E4IU0HDO)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SQUALANE (UNII: GW89575KF9)  
SHEA BUTTER (UNII: K49155WL9Y)  
CERAMIDE EOS (UNII: CR0J8RN66K)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CARBOMER 980 (UNII: 4Q93RCW27E)  
EUGENOL (UNII: 3T8H1794QW)  
HEXYL CINNAMATE (UNII: 532UJ0Y6RI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72414-005-5050 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/2022
2NDC:72414-005-1515 g in 1 APPLICATOR; Type 0: Not a Combination Product07/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/01/2022
Labeler - Haute Custom Beauty (024442805)
Registrant - Haute Custom Beauty (466493781)
Establishment
NameAddressID/FEIBusiness Operations
Haute Custom Beauty SLU466493781manufacture(72414-000, 72414-001, 72414-002, 72414-003, 72414-004, 72414-005, 72414-006) , label(72414-000, 72414-001, 72414-002, 72414-003, 72414-004, 72414-005, 72414-006)

Revised: 11/2022
Document Id: ecb3c837-e762-5651-e053-2995a90a6093
Set id: 701a668d-452b-cb3d-e053-2a91aa0a785f
Version: 4
Effective Time: 20221105
 
Haute Custom Beauty