4129 Premium Age Protector SPF 30

Premium Age Protector by

Drug Labeling and Warnings

Premium Age Protector 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- ethylhexyl methoxyci nnamate cream cream 
Inspira: Cosmetics GmbH

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4129 Premium Age Protector SPF 30

Active Ingredient

Active Ingredients: ethylhexyl methoxy­cinnamate and octocrylene

Inactive Ingredients

Other Ingredients: Aqua [water], propylheptyl caprylate, octocrylene, butylene glycol, methyl glucose sesquistearate, hydrogenated polyisobutene, sodium potassium aluminum silicate, gly­cerin, steareth-21, BIS-ethylhexyloxyphenol, methoxyphenyl triazine, ethylhexyl triazone, cetearyl alcohol, glyceryl stearate, phenyl trimethi­cone, sigesbeckia orientalis extract, rabdosia rubescens extract, tomes officinalis (mushroom] extract, retinyl palmitate, helianthus annuus [sunflower] seed oil, faex extract [yeast extract], aluminum hydroxide, soy isoflavones, lepidium sativum sprout extract, PEG-40 hydrogenated castor oil, polysorbate 80, lecithin, silica, hydrogen dimethicone, sodium levulinate, levulinic acid, titanium dioxide (nano), ascorbyl sodium levulinate, levulinic acid, titanium dioxide (nano), ascorbyl palmitate, tocopherol, BHT, disodium EDTA, alcohol, ethylhexyl-1) glycerin, citric acid, parfum [fragrance], phenoxyethanol, sodium benzoate, sodium dehydroacetate, methyl benzoate, Cl 77 891 [titanium dioxide], Cl 15 985 [yellow 6]

Principlay Panel

4129 Premium Age Protector SPF30

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 and octocrylene

Other Ingredients: Aqua [water], propylheptyl caprylate, octocrylene, butylene glycol, methyl glucose sesquistearate, hydrogenated polyisobutene, sodium potassium aluminum silicate, gly­cerin, steareth-21, BIS-ethylhexyloxyphenol, methoxyphenyl triazine, ethylhexyl triazone, cetearyl alcohol, glyceryl stearate, phenyl trimethi­cone, sigesbeckia orientalis extract, rabdosia rubescens extract, tomes officinalis (mushroom] extract, retinyl palmitate, helianthus annuus [sunflower] seed oil, faex extract [yeast extract], aluminum hydroxide, soy isoflavones, lepidium sativum sprout extract, PEG-40 hydrogenated castor oil, polysorbate 80, lecithin, silica, hydrogen dimethicone, sodium levulinate, levulinic acid, titanium dioxide (nano), ascorbyl sodium levulinate, levulinic acid, titanium dioxide (nano), ascorbyl palmitate, tocopherol, BHT, disodium EDTA, alcohol, ethylhexyl-1) glycerin, citric acid, parfum [fragrance], phenoxyethanol, sodium benzoate, sodium dehydroacetate, methyl benzoate, Cl 77 891 [titanium dioxide], Cl 15 985 [yellow 6]

Direction: Every morning, after cleansing evenly spread a small amount of cream over you face, neck and the area above your neckline and gently rub it in. Avoid the skin around your eyes

4129 Premium Age Protector SPF30

PREMIUM AGE PROTECTOR 
ethylhexyl methoxyci nnamate cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70493-429
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.49 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
METHYL BENZOATE (UNII: 6618K1VJ9T)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ETHYLHEXYL TRIAZONE (UNII: XQN8R9SAK4)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
SIGESBECKIA ORIENTALIS FLOWERING TOP (UNII: 6UL878YAR7)
POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C)
STEARETH-21 (UNII: 53J3F32P58)
BEMOTRIZINOL (UNII: PWZ1720CBH)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
GLYCERIN (UNII: PDC6A3C0OX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALCOHOL (UNII: 3K9958V90M)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
YEAST (UNII: 3NY3SM6B8U)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SOY ISOFLAVONES (UNII: 71B37NR06D)
GARDEN CRESS SPROUT (UNII: PWQ18YNR62)
WATER (UNII: 059QF0KO0R)
METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D)
ISODON RUBESCENS TOP (UNII: 03NNJ0PH79)
LARICIFOMES OFFICINALIS FRUITING BODY (UNII: 7IFM8431X3)
LEVULINIC ACID (UNII: RYX5QG61EI)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70493-429-01	1 in 1 BOX	02/16/2022	02/16/2022
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	02/16/2022	02/16/2022

Labeler - Inspira: Cosmetics GmbH (329455898)

Registrant - Inspira: Cosmetics GmbH (329455898)

Establishment
Name	Address	ID/FEI	Business Operations
Inspira: Cosmetics GmbH		329455898	manufacture(70493-429)

Revised: 8/2024

Document Id: 1f313ceb-1c46-391c-e063-6394a90a65df

34390-5

Set id: d748e291-3a26-663c-e053-2995a90a8d92

Version: 2

Effective Time: 20240808