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

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70809-1602
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	9 mg  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	9 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70809-1602-1	120 mL in 1 TUBE; Type 0: Not a Combination Product	07/25/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/25/2016	01/01/2017

Labeler - Urban Skin Solutions (807305417)

Registrant - Urban Skin Solutions (807305417)

Establishment
Name	Address	ID/FEI	Business Operations
Urban Skin Solutions		807305417	label(70809-1602) , api manufacture(70809-1602)

Revised: 6/2019

Document Id: 8b3525ee-e140-f032-e053-2a95a90a6f3e

34390-5

Set id: 386eeffc-36bd-4e24-e054-00144ff8d46c

Version: 2

Effective Time: 20190613