ULTRA UV DEFENSE SPF 30- zinc oxide cream

Ultra UV Defense SPF 30 by

Drug Labeling and Warnings

Ultra UV Defense SPF 30 by is a Otc medication manufactured, distributed, or labeled by Jenelt Cosmetics, CoValence Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Zinc Oxide 13.5%

PURPOSE

Purpose:  Sunscreen

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

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.
  

DOSAGE & ADMINISTRATION

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 INGREDIENT

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 SAFETY INFORMATION

Other Information:

• Protect this product from excessive heat and direct sun.
  

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ULTRA UV DEFENSE SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58469-6100(NDC: 66915-610)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.135 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58469-6100-1	60 g in 1 TUBE; Type 0: Not a Combination Product	03/26/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/26/2014

Labeler - Jenelt Cosmetics (078802794)

Registrant - CoValence Laboratories (070653204)

Establishment
Name	Address	ID/FEI	Business Operations
CoValence Laboratories		070653204	manufacture(58469-6100)