Clarifying Complexion Protection SPF 30

Drug Labeling and Warnings

Drug Details [pdf]

CLARIFYING COMPLEXION PROTECTION- zinc oxide 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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Clarifying Complexion Protection SPF 30

ACTIVE INGREDIENT - ZINC OXIDE 20%

Sunscreen

FOR EXTERNAL USE ONLY

DO NOT USE - On damaged or broken skin

STOP USE AND ASK A DOCTOR IF A RASH OCCURRS

CLARIFYING COMPLEXION PROTECTION 
zinc oxide cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70809-1603
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
WATER (UNII: 059QF0KO0R)
JOJOBA OIL (UNII: 724GKU717M)
MONTMORILLONITE (UNII: A585MN1H2L)
ALMOND OIL (UNII: 66YXD4DKO9)
SOYBEAN OIL (UNII: 241ATL177A)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
GLYCERIN (UNII: PDC6A3C0OX)
DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE (UNII: 38H206R00R)
ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)
HYALURONIC ACID (UNII: S270N0TRQY)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ROSA RUBIGINOSA SEED OIL (UNII: 8M1P49MWAP)
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)
BORAGE OIL (UNII: F8XAG1755S)
AVOCADO OIL (UNII: 6VNO72PFC1)
SULFUR (UNII: 70FD1KFU70)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ASIAN GINSENG (UNII: CUQ3A77YXI)
LEVOMENOL (UNII: 24WE03BX2T)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
GINKGO (UNII: 19FUJ2C58T)
USNEA BARBATA (UNII: D6DVA9TCAP)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
PEPPERMINT OIL (UNII: AV092KU4JH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70809-1603-1	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(70809-1603) , api manufacture(70809-1603)

Revised: 6/2019

Document Id: 8b3525ee-e135-f032-e053-2a95a90a6f3e

34390-5

Set id: 3876aa00-66ec-3ad4-e054-00144ff8d46c

Version: 2

Effective Time: 20190613