LIVE ULTIMATE FACIAL SUNSCREEN SPF30 SPF 30- zinc oxide cream

Live Ultimate Facial Sunscreen SPF30 by

Drug Labeling and Warnings

Live Ultimate Facial Sunscreen SPF30 by is a Otc medication manufactured, distributed, or labeled by Owen Biosciences Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients                  Purpose

Zinc Oxide 21.0%                 Sunscreen

PURPOSE

USES

• Helps prevent Sunburn
• If used as directed with other sun protection measures it can decrease 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.  Stop and ask a doctor if rash occurs.

When using this product keep out of eyes.  Rinse with water to remove.

Keep out of reach of children If product is swallowed, get medical help or contact Poison Control Center immdeiately.

INDICATIONS & USAGE

• For full protection, apply liberally 15 minutes before sun exposure
• Reapply every 2 hours, after towel drying or swimming

Sun Protection Measures:

• Spending time  in the sun increases your risk of skin cancer and early skin aging
• Decrease the risk by using sunscreen with a broad spectrum SPF calue of 15 or higher
• Limit time in the sun, especially from 10am - 2pm
• Ask doctor for children under 6 months

INACTIVE INGREDIENT

Inactive Ingredients

Purified Water (Aqua), Allantoin, Organic Aloe Barbadenis Leaf Juice, Argania Spinosa Kernel (Argan) Oil, Ascorbyl Linoleate, Astaxanthin (Algae Derived), Organic Butyrospermum Parkii (Shea) Butter, Organic Camellia Sinensis Leaf Extract (Green Tea), Caprylic/Capric Triglyceride, Organic Carthamus tinctoris (Safflower) Seed Oil, Cetearyl Alcohol, Vetearyl Glucoside, Cetearyl Olivate, Organic Chamomilla Recutita (Matricaria) Flower Extract (Chamomile), Coco-Caprylate/-Caprate Cocoglycerides (Coconut derived), Coconut Alkanes, Organic Cocos Nucifera (Coconut) Oil, Copernicia Cerifera (Carnauba) Wax, Ethyl Macadamiate (Macadamia Nut Derived), Glycerin, Glyceryl Caprylate, Glyceryl Isostearate, Glyceryl Undecylenate, Iron Oxides, Lysolecithin (Lescithin), Lysophosphaditic Acid, Organic Myrciara Dubia Fruit Extract (Camu Camu), Myristoyl Pentapeptide-17, p-Anisicacid, Polyglyceryl-3 Polyhdroxystearic Acid, Propanediol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Chloride, Sodium Hyaluronate (Hyaluronic Acid), Sorbitan Olivate, Organic Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Linoleate/Oleate, Triethoxycaprylylsilane, Xanthan Gum

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

LIVE ULTIMATE FACIAL SUNSCREEN SPF30  SPF 30
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59958-230
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	21 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	34.0 g  in 100 g
ETHYL MACADAMIATE (UNII: ANA2NCS6V1)	5   in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	5   in 100 g
PROPANEDIOL (UNII: 5965N8W85T)	5   in 100 g
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)	4   in 100 g
JOJOBA OIL (UNII: 724GKU717M)	15   in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59958-230-01	1 in 1 CARTON	05/05/2015
1	NDC: 59958-230-02	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/05/2015

Labeler - Owen Biosciences Inc (790003045)

Registrant - Owen Biosciences Inc (790003045)

Establishment
Name	Address	ID/FEI	Business Operations
Owen Biosciences Inc		790003045	manufacture(59958-230)