Your browser does not support JavaScript! DAYTIME DEFENSE SPF 30 (ZINC OXIDE) CREAM [COVALENCE, INC.]
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DAYTIME DEFENSE SPF 30 (zinc oxide) cream
[CoValence, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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: 

  • Helps prevent sunburn
  • For skin highly sensitive to sunburn

Warnings:

  • For external use only
  • Do not use on damaged or broken skin
  • When using this product keep out of eyes.  Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs
  • Keep out of reach of children.  If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Apply liberally 15 minutes before sun exposure.
  • Use water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • Sun Protection Measures.  Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:  Limit time in the sun, especially from 10 a.m. - 2 p.m.  Wear long-sleeve shirts, pants, hats and sunglasses.

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
 
CoValence, Inc.

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