Active Daily Defense SPF 45

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE DAILY DEFENSE- 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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Active Daily Defense SPF 45

ACTIVE INGREDIENT - ZINC OXIDE 12%

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: CERTIFIED ORGANIC ALOE VERA, ALPHA LIPOIC ACID, VITAMIN C, VITAMIN E, VITAMIN D, GRAPE SEED EXTRACT, EVENING PRIMROSE, SUNFLOWER SEED, SAFFLOWER SEED, SLIPPERY ELM, BORAGE OIL, ALPHA BISABOLOL (CHAMOMILE), PLANTAINS, ALLANTOIN, HYALURONIC ACID, AND SQUALANE.

ACTIVE DAILY DEFENSE 
zinc oxide cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70809-1601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
VITAMIN D (UNII: 9VU1KI44GP)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
OENOTHERA BIENNIS (UNII: 76UI55V071)
SUNFLOWER SEED (UNII: R9N3379M4Z)
SAFFLOWER SEED (UNII: 8FCL6A31TX)
ELM (UNII: 63POE2M46Y)
BORAGE OIL (UNII: F8XAG1755S)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
PLANTAGO MAJOR (UNII: W2469WNO6U)
HYALURONIC ACID (UNII: S270N0TRQY)
SQUALENE (UNII: 7QWM220FJH)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70809-1601-1	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(70809-1601) , api manufacture(70809-1601)

Revised: 6/2019

Document Id: 8b3525ee-e14b-f032-e053-2a95a90a6f3e

34390-5

Set id: 383dc8fa-8205-4fdb-e054-00144ff8d46c

Version: 3

Effective Time: 20190613