PETER ISLAND NATURAL MINERALSPF 60  SPF 60- titanium dioxide zinc oxide lotion 
Access Business Group LLC

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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Drug Facts

Active ingredients

Titanium Dioxide 2.8%

Zinc Oxide 4.0%


Purpose

Sunscreen

Warnings

For external use only.
Do not use on damaged skin or broken skin. Rinse with water to remove


When using this product keep out of eyes.


stop use and ask a doctor if rash occurs


Keep out of reach of children.


If product is swallowed, get medical help or contact a Poison Control Center right away.

May stain some fabrics.

DIRECTIONS:

Sun protection measures.

Spending time in the sun increase 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:



OTHER INFORMATION:

protect this product from excessive heat and direct sun


Uses

Principal Display Panel

PETER

ISLAND

NATURAL MINERAL

SUNSCREEN LOTION

100%

Naturally

Sourced

Sunscreen

Ingredients

with Zinc Oxide and Titanium Dioxide

BROAD SPECTRUM

SPF 60

Dermatologist Tested

UVA/UVB Protection

Water Resistant (80 Minutes)

4 Fl. OZ. (118 mL)

ZU0011A0.jpg

INACTIVE INGREDIENTS:

Water, Caprylic Capric Triglyceride, Butyloctyl Salicylate, Phenethyl Benxoate, Cetyl PEG/PPG-10/1 Dimethicone, Laurly PEG-8 Dimethicone, Ozokerite, Cyclopentasiloxane, Cyclohexasiloxane , C30-38 Olefin/Isopropyl Maleate MA Copolymer, Ethylhexyl Methocrylene, PEG-8, Sodium Chloride, Caprylyl Glycol, Dimethicone, Alumina, Methicone, Glycerin, Sodium Citrate, Disodium EDTA, Panthenol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Phenoxyethanol.


PETER ISLAND NATURAL MINERALSPF 60   SPF 60
titanium dioxide zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-708
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.8 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TRICAPRIN (UNII: O1PB8EU98M)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PANTHENOL (UNII: WV9CM0O67Z)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10056-708-23118 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/08/2013
Labeler - Access Business Group LLC (839830713)

Revised: 7/2013
Document Id: 118f62aa-85b4-4032-9ce6-0e5ba6c16414
Set id: 6a42a670-f222-483c-a600-06e04957402f
Version: 1
Effective Time: 20130708
 
Access Business Group LLC