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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:66915-611
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE.135 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
MEDIUM-CHAIN TRIGLYCERIDES 
ETHYL MACADAMIATE 
ISODECYL NEOPENTANOATE 
GLYCERIN 
GLYCERYL MONOSTEARATE 
BARLEY 
LAVENDER OIL 
SANDALWOOD 
PHELLODENDRON AMURENSE BARK 
ARTEMISIA VULGARIS ROOT 
.ALPHA.-TOCOPHEROL, DL- 
MALIC ACID, L- 
LONICERA CAPRIFOLIUM FLOWER 
LONICERA JAPONICA FLOWER 
GLYCERYL ISOSTEARATE 
SODIUM STEAROYL LACTYLATE 
DOCOSANOL 
CETOSTEARYL ALCOHOL 
POLYHYDROXYSTEARIC ACID (2300 MW) 
SODIUM CHLORIDE 
HAMAMELIS VIRGINIANA TOP WATER 
ALCOHOL 
CITRIC ACID MONOHYDRATE 
FYTIC ACID 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66915-611-01200000 g in 1 DRUM
2NDC:66915-611-0230 g in 1 BOTTLE, PLASTIC
3NDC:66915-611-03120 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/26/2012
Labeler - CoValence, Inc. (070653204)
Registrant - CoValence, Inc. (070653204)
Establishment
NameAddressID/FEIBusiness Operations
CoValence, Inc.070653204manufacture(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.