Premium Age Protector Ultra

Premium Age Protector Ultra by

Drug Labeling and Warnings

Premium Age Protector Ultra by is a Otc medication manufactured, distributed, or labeled by Inspira Cosmetics GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PREMIUM AGE PROTECTOR ULTRA- premium age protector ultra cream 
Inspira Cosmetics GmbH

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Premium Age Protector Ultra

Inactive Ingredient

Other Ingredients: Aqua [water], propylheptyl caprylate, , butylene glycol, methyl glucose sesquistearate, diethylamino hydroxybenzoyl hexyl benzoate, hydrogenated polyisobutene, sodium potassium aluminum silicate, glycerin, silica, steareth-21, methylene 8IS-benzotriazolyl tetramethylbutylphenol (nano), 8IS-ethylhexyloxyphenol methoxyphenyl triazine, cetearyl alcohol, pentylene glycol, glyceryl stearate, phenyl trimethicone, allantoin, retinyl palmitate, enantia chlorantha bark extract, aluminum hydroxide, oleanolic acid, glyceryl caprylate, helianthus annuus (sunflower) CO seed oil, xanthan gum, decyl glucoside, lecithin, hydrogen dimethicone, titanium dioxide (nano), ascorbyl palmitate, tocopherol,BHT, sodium tetrasodium hydroxide, glutamate parfum diacetate, [fragrance], propylene phenoxyethanol, glycol, citric acid Cl T-Ct) 77 891 [titanium dioxide]

Active Ingredients

Active Ingredients: ethylhexyl methoxy­cinnamate, octocrylene

Package Label Principal Display Panel

4128 Premium Age Protector Ultra SPF30

Ethylhexyl methoxycinnamate and Octocrylene day cream by inspira:cosmetics GbmH

Disclaimer: Most OTC drugs are not review and approved by FDA; however, they are marketed if they comply with applicable and policies

Active Ingredients: ethylhexyl methoxycinnamate, octocrylene

Other Ingredients: Aqua [water], propylheptyl caprylate, , butylene glycol, methyl glucose sesquistearate, diethylamino hydroxybenzoyl hexyl benzoate, hydrogenated polyisobutene, sodium potassium aluminum silicate, glycerin, silica, steareth-21, methylene 8IS-benzotriazolyl tetramethylbutylphenol (nano), 8IS-ethylhexyloxyphenol methoxyphenyl triazine, cetearyl alcohol, pentylene glycol, glyceryl stearate, phenyl trimethicone, allantoin, retinyl palmitate, enantia chlorantha bark extract, aluminum hydroxide, oleanolic acid, glyceryl caprylate, helianthus annuus (sunflower) CO seed oil, xanthan gum, decyl glucoside, lecithin, hydrogen dimethicone, titanium dioxide (nano), ascorbyl palmitate, tocopherol,BHT, sodium tetrasodium hydroxide, glutamate parfum diacetate, [fragrance], propylene phenoxyethanol, glycol, citric acid Cl T-Ct) 77 891 [titanium dioxide]

PREMIUM AGE PROTECTOR ULTRA 
premium age protector ultra cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70493-428
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ALLANTOIN (UNII: 344S277G0Z)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BISOCTRIZOLE (UNII: 8NT850T0YS)
POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
STEARETH-21 (UNII: 53J3F32P58)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
BEMOTRIZINOL (UNII: PWZ1720CBH)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70493-428-02	1 in 1 BOX	02/15/2022	02/15/2022
1		50 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/15/2022	02/15/2022

Labeler - Inspira Cosmetics GmbH (329455898)

Establishment
Name	Address	ID/FEI	Business Operations
Inspira Cosmetics GmbH		329455898	manufacture(70493-428)

Revised: 8/2024

Document Id: 1f3141c6-dc35-ffca-e063-6294a90a94f2

34390-5

Set id: d78c29fc-5804-3c3f-e053-2995a90a082b

Version: 3

Effective Time: 20240808