ELITE NATURAL 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 OTC #610; Elite Natural SPF 30


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.

66915 610 06

ELITE NATURAL SPF 30 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66915-610
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.135 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
KUKUI NUT OIL (UNII: TP11QR7B8R)  
HAMAMELIS VIRGINIANA LEAF WATER (UNII: 8FP93ED6H2)  
ERGOTHIONEINE (UNII: BDZ3DQM98W)  
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
BARLEY (UNII: 5PWM7YLI7R)  
MACADAMIA OIL (UNII: 515610SU8C)  
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
SANDALWOOD (UNII: 3641YW25N2)  
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
POLYGLYCERIN-10 (UNII: P9060O936A)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
TOCOPHEROL (UNII: R0ZB2556P8)  
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)  
MALIC ACID (UNII: 817L1N4CKP)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)  
ALCOHOL (UNII: 3K9958V90M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DOCOSANOL (UNII: 9G1OE216XY)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
PHYTIC ACID (UNII: 7IGF0S7R8I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66915-610-0130 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2011
2NDC:66915-610-0260 g in 1 TUBE; Type 0: Not a Combination Product08/31/201104/14/2015
3NDC:66915-610-0360 g in 1 TUBE; Type 0: Not a Combination Product08/31/2011
4NDC:66915-610-04180 g in 1 TUBE; Type 0: Not a Combination Product08/31/2011
5NDC:66915-610-05105 g in 1 TUBE; Type 0: Not a Combination Product08/31/2011
6NDC:66915-610-06200000 g in 1 DRUM; Type 0: Not a Combination Product08/31/2011
7NDC:66915-610-077.5 g in 1 JAR; Type 0: Not a Combination Product08/31/201104/14/2015
8NDC:66915-610-087.5 g in 1 JAR; Type 0: Not a Combination Product08/31/2011
9NDC:66915-610-097.5 g in 1 JAR; Type 0: Not a Combination Product08/31/2011
10NDC:66915-610-1015 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/31/2011
11NDC:66915-610-191 in 1 BOX08/31/2011
11NDC:66915-610-1170 g in 1 TUBE; Type 0: Not a Combination Product
12NDC:66915-610-1460 g in 1 TUBE; Type 0: Not a Combination Product08/31/2011
13NDC:66915-610-1550 g in 1 TUBE; Type 0: Not a Combination Product08/31/2011
14NDC:66915-610-16120 g in 1 TUBE; Type 0: Not a Combination Product08/31/2011
15NDC:66915-610-17120 g in 1 TUBE; Type 0: Not a Combination Product08/31/2011
16NDC:66915-610-1850 g in 1 TUBE; Type 0: Not a Combination Product08/31/2011
17NDC:66915-610-2030 g in 1 TUBE; Type 0: Not a Combination Product08/31/201104/14/2015
18NDC:66915-610-21120 g in 1 TUBE; Type 0: Not a Combination Product08/31/201104/14/2015
19NDC:66915-610-22120 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/31/201104/14/2015
20NDC:66915-610-1230 g in 1 TUBE; Type 0: Not a Combination Product04/14/2015
21NDC:66915-610-231 g in 1 PACKAGE; Type 0: Not a Combination Product04/14/2015
22NDC:66915-610-24110 g in 1 TUBE; Type 0: Not a Combination Product04/14/2015
23NDC:66915-610-25100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2015
24NDC:66915-610-2645 g in 1 JAR; Type 0: Not a Combination Product04/14/2015
25NDC:66915-610-2830 g in 1 TUBE; Type 0: Not a Combination Product04/14/2015
26NDC:66915-610-30215 g in 1 TUBE; Type 0: Not a Combination Product04/14/2015
27NDC:66915-610-3175 g in 1 TUBE; Type 0: Not a Combination Product04/14/2015
28NDC:66915-610-34160 g in 1 TUBE; Type 0: Not a Combination Product04/14/2015
29NDC:66915-610-3555 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2015
30NDC:66915-610-3660 g in 1 TUBE; Type 0: Not a Combination Product04/14/2015
31NDC:66915-610-3860 g in 1 TUBE; Type 0: Not a Combination Product03/26/2014
32NDC:66915-610-4030 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2015
33NDC:66915-610-4380 g in 1 TUBE; Type 0: Not a Combination Product04/14/2015
34NDC:66915-610-44230 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/14/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/31/2011
Labeler - CoValence, Inc. (070653204)
Establishment
NameAddressID/FEIBusiness Operations
CoValence, Inc.070653204manufacture(66915-610)

Revised: 4/2015
 
CoValence, Inc.