PREMIUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide lotion 
Eden Brands

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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Premium Mineral Sunscreen Broad Spectrum SPF 30

Active ingredients Purpose

Zinc Oxide 22% Sunscreen

Uses

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

Stop use and ask a doctor if rash occurs.

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.

Directions:

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.

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

box

Primary

PREMIUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72113-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72113-101-0185 g in 1 BOX; Type 0: Not a Combination Product02/12/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35202/12/2018
Labeler - Eden Brands (081062339)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Laboratories Pty. Ltd.740537709manufacture(72113-101)

Revised: 2/2018
Document Id: 650a1595-a018-b221-e053-2991aa0a98d5
Set id: 650a1595-a017-b221-e053-2991aa0a98d5
Version: 1
Effective Time: 20180212
 
Eden Brands