Label: ULTRA UV DEFENSE SPF 30- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58469-6100-1 - Packager: Jenelt Cosmetics
- This is a repackaged label.
- Source NDC Code(s): 66915-610
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated November 11, 2015
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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.
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Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.
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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.
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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.
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ULTRA UV DEFENSE SPF 30
zinc oxide creamProduct 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)