PETER ISLAND NATURAL MINERALSPF 60 SPF 60- titanium dioxide zinc oxide lotion

PETER ISLAND NATURAL MINERALSPF 60 by

Drug Labeling and Warnings

PETER ISLAND NATURAL MINERALSPF 60 by is a Otc medication manufactured, distributed, or labeled by Access Business Group LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• apply literally 15 minutes before sun exposure
• reapply: after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours

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:

• Limit time in the sun, especially from 10 am - 2 pm
• Wear long sleeves shirts, pants, hats and sunglasses
• children under 6 month of age: Ask a doctor

OTHER INFORMATION:

protect this product from excessive heat and direct sun

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions).
• decrease the risk of skin cancer and early skin caused by the sun.

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)

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.

INGREDIENTS AND APPEARANCE

PETER ISLAND NATURAL MINERALSPF 60   SPF 60
titanium dioxide zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10056-708
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.8 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10056-708-23	118 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/08/2013

Labeler - Access Business Group LLC (839830713)