Age Defying Mineral Moisturizer SPF 45

Drug Labeling and Warnings

Drug Details [pdf]

AGE DEFYING MINERAL MOISTURIZER- zinc oxide, octinoxate cream cream 
Urban Skin Solutions

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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Age Defying Mineral Moisturizer SPF 45

Age Defying Mineral Moisturizer.PDPAge Defying Mineral Moisturizer

ACTIVE INGREDIENT - ZINC OXIDE 9% OCTINOXATE 9%

Sunscreen

FOR EXTERNAL USE ONLY

DO NOT USE - On damaged or broken skin

STOP USE AND ASK A DOCTOR IF A RASH OCCURRS

INACTIVE INGREDIENTS: PURIFIED WATER (AQUA), SIMMONDSIA (JOJOBA), CHINENSIS SEED OIL, ACETYL HEXAPEPTIDE-8, SQUALANE, EDELWEISS, GLYCINE SOJA (SOYBEAN) OIL, RETINOL, LECITHIN, GLYCOLIPIDS, CAMELLIA SINENSIS LEAF (GREEN TEA) EXTRACT, GLYCERIN, DIPEPTIDE DIAMINOBUTYROYL, BENZYLAMIDE DIACETATE, SODIUM HYALURONATE, POTASSIUM SORBATE, HEXYLENE GLYCOL, MALVA SYLVESTRIS EXTRACT, MENTHA PIPERITA LEAF EXTRACT, PRIMULA VERIS EXTRACT, ALCHEMILLA VULGARIS EXTRACT, VERONICA OFFICINALIS EXTRACT, MELISSA OFFICINALIS LEAF EXTRACT, ACHILLEA MILLEFOLIUM EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, TRIETHANOLAMINE, ROSA CANINA (ROSEHIPS) EXTRACT, MALUS DOMESTICA FRUIT CELL CULTURE, XANTHAM GUM, MICA, IRON OXIDES, PANAX GINSENG EXTRACT, ASCORBIC ACID, CREATINE, PUNICA GRANATUM (POMEGRANATE) EXTRACT, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL.

AGE DEFYING MINERAL MOISTURIZER 
zinc oxide, octinoxate cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 70809-1602
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE9 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE9 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
WATER (UNII: 059QF0KO0R)  
JOJOBA OIL (UNII: 724GKU717M)  
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
LEONTOPODIUM ALPINUM FLOWER (UNII: MWN6IZU3XM)  
SOYBEAN OIL (UNII: 241ATL177A)  
RETINOL (UNII: G2SH0XKK91)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE (UNII: 38H206R00R)  
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)  
VERONICA OFFICINALIS LEAF (UNII: 96R87REA55)  
MELISSA OFFICINALIS (UNII: YF70189L0N)  
TRICAPRIN (UNII: O1PB8EU98M)  
ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
TEA TREE OIL (UNII: VIF565UC2G)  
PRIMULA VERIS (UNII: W6LFQ57E4M)  
PANAX GINSENG FLOWER (UNII: 3V5S2B524J)  
TROLAMINE (UNII: 9O3K93S3TK)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
CREATINE (UNII: MU72812GK0)  
SQUALENE (UNII: 7QWM220FJH)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 70809-1602-1120 mL in 1 TUBE; Type 0: Not a Combination Product07/25/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/25/201601/01/2017
Labeler - Urban Skin Solutions (807305417)
Registrant - Urban Skin Solutions (807305417)
Establishment
NameAddressID/FEIBusiness Operations
Urban Skin Solutions807305417label(70809-1602) , api manufacture(70809-1602)

Revised: 6/2019
 

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