NECK DECOLLETE HAND ARM DAY REPARATIVE HYDRATION RESCUE AND REPROGRAM BROAD SPECTRUM SPF 35 SUNSCREEN- neck and decollete day 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.

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PACKAGE LABEL

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Active Ingredients

Product

Product

NECK DECOLLETE HAND ARM DAY REPARATIVE HYDRATION RESCUE AND REPROGRAM BROAD SPECTRUM SPF 35 SUNSCREEN 
neck and decollete day cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72414-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE6 g  in 100 g
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE4 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PANTHENOL (UNII: WV9CM0O67Z)  
DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
DECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7)  
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
SESAME OIL (UNII: QX10HYY4QV)  
CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
BELLIS PERENNIS (UNII: 2HU33I03UY)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
FYTIC ACID (UNII: 7IGF0S7R8I)  
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
ACEFYLLINE METHYLSILANOL MANNURONATE (UNII: OI1T4Z23RZ)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
VIOLA ODORATA (UNII: AET12U8B74)  
SHEA BUTTER (UNII: K49155WL9Y)  
NIACINAMIDE (UNII: 25X51I8RD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72414-007-6060 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/18/2023
2NDC:72414-007-20200 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/18/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/18/2023
Labeler - Haute Custom Beauty (024442805)
Registrant - Haute Custom Beauty (466493781)
Establishment
NameAddressID/FEIBusiness Operations
Haute Custom Beauty SLU466493781manufacture(72414-007) , label(72414-007) , pack(72414-007)

Revised: 8/2023
Document Id: 03339124-dd00-328e-e063-6394a90a68dc
Set id: 03339124-dcff-328e-e063-6394a90a68dc
Version: 1
Effective Time: 20230818
 
Haute Custom Beauty