Elite Natural SPF 30

Dosage form: cream
Ingredients: ZINC OXIDE .135mg in 1g
Labeler: CoValence, Inc.
NDC Code: 66915-610

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.

Drug Facts


Active Ingredient:
Zinc Oxide 13.5%

Purpose:  Sunscreen

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

Uses: 

  • Helps prevent sunburn.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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 the product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Apply liberally 15 minutes before sun exposure.
  • Use a 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.
  • Children under 6 months:  Ask a doctor.

Inactive Ingredients:  Aqua (Water), Caprylic/Capric Triglyceride, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Glycerin, Isodecyl Neopentanoate, Ethyl Macadamiate, Aleurites Moluccana Seed Oil, Hydroxypropyl Starch Phosphate, Glyceral Stearate, Hamamelis Virginiana (Witch Hazel) Water, Ergothioneine (L), Hordeum Distichon (Barley) Extract, Macadamia Ternifolia Seed Oil, Porphyra Umbilicalis (Red Algae) Extract, Santalum Album (Sandalwood) Extract, Phellodendron Amurense Bark Extract, Glyceryl Isostearate, Sodium Stearoyl Lactylate, Polyglyceryl-10 Pentastearate, Polyhydroxystearic Acid, Tocopheryl Acetate (D-alpha), Tocopherol (D-alpha), Lecithin, Malic Acid (L) Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Potassium Cetyl Phosphate, Hydrogenated Palm Glycerides, Alcohol, Cetearyl Alcohol, Behenyl Alchohol, Hydroxypropyl Methylcellulose, Sodium Lactate, Phytic Acid, Citric Acid, Sodium Hydroxide

Other Information:

  • Protect this product from excessive heat and direct sun.

Principal Display Panel 

ELITE NATURAL SPF 30 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66915-610
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 
GLYCERIN 
ISODECYL NEOPENTANOATE 
ETHYL MACADAMIATE 
KUKUI NUT OIL 
HAMAMELIS VIRGINIANA LEAF WATER 
ERGOTHIONEINE 
BARLEY 
MACADAMIA OIL 
PORPHYRA UMBILICALIS 
SANDALWOOD 
PHELLODENDRON AMURENSE BARK 
GLYCERYL ISOSTEARATE 
SODIUM STEAROYL LACTYLATE 
POLYGLYCERIN-10 
POLYHYDROXYSTEARIC ACID (2300 MW) 
.ALPHA.-TOCOPHEROL ACETATE, D- 
TOCOPHEROL 
EGG PHOSPHOLIPIDS 
MALIC ACID 
LONICERA CAPRIFOLIUM FLOWER 
LONICERA JAPONICA FLOWER 
POTASSIUM CETYL PHOSPHATE 
HYDROGENATED PALM GLYCERIDES 
ALCOHOL 
CETOSTEARYL ALCOHOL 
DOCOSANOL 
HYPROMELLOSE 2208 (100 MPA.S) 
SODIUM LACTATE 
PHYTIC ACID 
CITRIC ACID MONOHYDRATE 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:66915-610-0130 g in 1 BOTTLE, PLASTIC
2NDC:66915-610-0260 g in 1 TUBE
3NDC:66915-610-0360 g in 1 TUBE
4NDC:66915-610-04180 g in 1 TUBE
5NDC:66915-610-05105 g in 1 TUBE
6NDC:66915-610-06200000 g in 1 DRUM
7NDC:66915-610-077.5 g in 1 JAR
8NDC:66915-610-087.5 g in 1 JAR
9NDC:66915-610-097.5 g in 1 JAR
10NDC:66915-610-1015 g in 1 BOTTLE, DISPENSING
11NDC:66915-610-191 TUBE (TUBE) in 1 BOX
11NDC:66915-610-1170 g in 1 TUBE
12NDC:66915-610-1460 g in 1 TUBE
13NDC:66915-610-1550 g in 1 TUBE
14NDC:66915-610-16120 g in 1 TUBE
15NDC:66915-610-17120 g in 1 TUBE
16NDC:66915-610-1850 g in 1 TUBE
17NDC:66915-610-2030 g in 1 TUBE
18NDC:66915-610-21120 g in 1 TUBE
19NDC:66915-610-22120 g in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/31/2011
Labeler - CoValence, Inc. (070659375)
Establishment
NameAddressID/FEIOperations
CoValence, Inc.070659375manufacture

Revised: 08/2011
 
CoValence, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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