ULTRA UV DEFENSE SPF 30- zinc oxide cream 
Jenelt Cosmetics

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; Ultra UV Defense 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: 

Warnings:

Directions:

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:

PDP

ULTRA UV DEFENSE SPF 30 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58469-6100(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:58469-6100-160 g in 1 TUBE; Type 0: Not a Combination Product03/26/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/26/2014
Labeler - Jenelt Cosmetics (078802794)
Registrant - CoValence Laboratories (070653204)
Establishment
NameAddressID/FEIBusiness Operations
CoValence Laboratories070653204manufacture(58469-6100)

Revised: 11/2015
Document Id: 244b582b-350a-382e-e054-00144ff8d46c
Set id: 244b582b-3509-382e-e054-00144ff8d46c
Version: 1
Effective Time: 20151111
 
Jenelt Cosmetics