DAYTIME DEFENSE SPF 30- zinc oxide cream 
CoValence, Inc.

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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Drug Facts

Active Ingredients:  Zinc Oxide 13.5%

Purpose:  Sunscreen

Warnings:  Keep our of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.

Use: 

Warnings:

Directions:

Inactive Ingredients:

Aqua (Water). Caprylic/Capric Triglyceride, Glycerin, Ethyl Macadamiate, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glyceryl Stearate, Isodecyl Neopentanoate, Polyglyceryl-10 Pentastearate, Hydrolyzed Starch Phosphate, Cirtric Acid, Cetearyl Alcohol, Sodium Stearoyl Lactylate, Behenyl Alcohol, Phellodendrom Amurense (Cork Tree) Bark Extract, Glyceryl Isostearate, Hydroxypropyl Methylcellulose, Sodium Stearoyl Lactylate, Alcohol Denatured, Santalum Album (Sandalwood) Extract, Hordeum Distichon (Barley) Extract, Artemisia Vulgaris (Mugwort) Extract, Algae Extract, Malic Acid, Tocopherol, Hamamelis Virginiana (Witch Hazel) Water, Lonicera Caprifolium (Honeysuckle) Flower Extract, Sodium Chloride, Sodium Hydroxide

Principal Display Panel:66915 611 02 Label

DAYTIME DEFENSE SPF 30 
zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66915-611
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE .135 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
BARLEY (UNII: 5PWM7YLI7R)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
SANDALWOOD (UNII: 3641YW25N2)  
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)  
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
MALIC ACID, L- (UNII: J3TZF807X5)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
DOCOSANOL (UNII: 9G1OE216XY)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
ALCOHOL (UNII: 3K9958V90M)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FYTIC ACID (UNII: 7IGF0S7R8I)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:66915-611-01 200000 g in 1 DRUM
2 NDC:66915-611-02 30 g in 1 BOTTLE, PLASTIC
3 NDC:66915-611-03 120 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/26/2012
Labeler - CoValence, Inc. (070653204)
Registrant - CoValence, Inc. (070653204)
Establishment
Name Address ID/FEI Business Operations
CoValence, Inc. 070653204 manufacture(66915-611)

Revised: 4/2012
Document Id: 8ea410a3-0ef1-4567-b367-390626c5e1fc
Set id: b4f0620a-e388-4fb5-af81-672b45a1bd70
Version: 1
Effective Time: 20120426
 
CoValence, Inc.