PREMIUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide lotion

Premium Mineral Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Premium Mineral Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Eden Brands, Baxter Laboratories Pty. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose

Zinc Oxide 22% Sunscreen

PURPOSE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

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.

DOSAGE & ADMINISTRATION

Directions:

• Apply liberally 15 minutes before sun exposure
• Reapply:
  • after 80 minutes of swimming or sweating
  • Immediately after towel drying
  • at least every two hours
  • Children under 6 months of age: ask a doctor
  • Sun Protection Measures: Spending time in the sun increases your risk of cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit your time in the sun, especially from 10a.m.-2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Inactive ingredients:

Caprylic/Capric Triglyceride, Vitis Vinifera (grape) Seed Extract, Butyrospermum Parkii (shea) Butter, Silica, Aluminum Starch Octenylsuccinate, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera, Beeswax/Cera Alba, Glyceryl Isostearate, Brassica Campestris/Aleurites Fordii Oil Copolymer, Polyhydroxystearic Acid, Simmondsia Chinensis (jojoba) Seed Oil, Tocopherol, Carthamus Tinctorious (Safflower) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Water/Aqua, Camelilla sinensis leaf Extract, Rosa Canina Fruit Oil.

PRINCIPAL DISPLAY PANEL

SPF 30 Premium Mineral Sunsreen

High Protection

Broad Spectrum SPF 30

Water resistant (80 minutes)

Mineral based Active Ingredient

Net Wt. 3.0oz / 85 g

INGREDIENTS AND APPEARANCE

PREMIUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72113-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
WHITE WAX (UNII: 7G1J5DA97F)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CUCUMBER (UNII: YY7C30VXJT)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
SAFFLOWER OIL (UNII: 65UEH262IS)
SHEA BUTTER (UNII: K49155WL9Y)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
GLYCERIN (UNII: PDC6A3C0OX)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CANDELILLA WAX (UNII: WL0328HX19)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72113-101-01	85 g in 1 BOX; Type 0: Not a Combination Product	02/12/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/12/2018

Labeler - Eden Brands (081062339)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laboratories Pty. Ltd.		740537709	manufacture(72113-101)