ARAMORE MULTI-DEFENSE SUNSCREEN - AM BROAD SPECTRUM SPF 30- zinc oxide lotion 
New Frontier Bio, Inc

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NEW FRONTIER (as PLD) - ARAMORE MULTI-DEFENSE SUNSCREEN LOTION SPF-30 (83127-101)

ACTIVE INGREDIENT

ZINC OXIDE 20%

PURPOSE

SUNSCREEN

USE

HELPS PREVENT SUNBURN

WARNINGS

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

Water (Aqua), Caprylic/Capric Triglyceride, Dimethicone, Glycerin, Cetearyl Alcohol, Polymethylsilsesquioxane, Propanediol, Coco-Glucoside, Sodium Hyaluronate, Ferulic Acid, Linoleic Acid, Linolenic Acid, Niacinamide, Bisabolol, Rutin, Tocopherol, Hydroxyacetophenone, Butyrospermum Parkii (Shea) Butter, Citrus Paradisi (Grapefruit) Peel Extract, Zingiber Officinale (Ginger) Root Extract, Ipomoea Batatas Root Extract, Oryza Sativa Hull Extract, Camellia Sinensis Leaf Extract, Lactobacillus Ferment Lysate, Saccharomyces Lysate, Sodium Stearoyl Glutamate, Tetrasodium Glutamate Diacetate, Polyglyceryl-3 Ricinoleate, Polyhydroxystearic Acid, Isostearic Acid, Glyceryl Caprylate, Cetearyl Glucoside, Decyl Glucoside, Glyceryl Oleate Citrate, Lecithin, Pullulan, Xanthan Gum, Sclerotium Gum, Polysilicone-11, Sodium Hydroxide, 1,2-Hexanediol, Pentylene Glycol, Caprylyl Glycol, Sodium Benzoate, Caprylhydroxamic Acid, Ethylhexyl Palmitate.

Aramore Packaging

ARAMORE MULTI-DEFENSE SUNSCREEN - AM  BROAD SPECTRUM SPF 30
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83127-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
PULLULAN (UNII: 8ZQ0AYU1TT)  
XANTHAN GUM (UNII: TTV12P4NEE)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PROPANEDIOL (UNII: 5965N8W85T)  
NIACINAMIDE (UNII: 25X51I8RD4)  
RUTIN (UNII: 5G06TVY3R7)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
SHEA BUTTER (UNII: K49155WL9Y)  
GRAPEFRUIT PEEL (UNII: 3582N05Q44)  
RICE GERM (UNII: 7N2B70SFEZ)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
LIMOSILACTOBACILLUS FERMENTUM (UNII: 2C1F12C6AP)  
COCO GLUCOSIDE (UNII: ICS790225B)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
LINOLENIC ACID (UNII: 0RBV727H71)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
LINOLEIC ACID (UNII: 9KJL21T0QJ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
FERULIC ACID (UNII: AVM951ZWST)  
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
GINGER (UNII: C5529G5JPQ)  
SWEET POTATO (UNII: M9WGG9Z9GK)  
SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
GLYCERYL MONOOLEATE CITRATE (UNII: NLE5KIG74K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83127-101-121 in 1 BOX12/09/2022
1NDC:83127-101-1150 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:83127-101-141 in 1 BOX12/09/2022
2NDC:83127-101-1315 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02012/09/2022
Labeler - New Frontier Bio, Inc (118602172)

Revised: 1/2024
Document Id: 103378de-0d04-1623-e063-6294a90ab51f
Set id: ef6c8443-fd10-2022-e053-2a95a90a45ea
Version: 3
Effective Time: 20240130
 
New Frontier Bio, Inc