PETER ISLAND SUNSCREEN SPF 50- octocrylene oxybenzone zinc oxide lotion

Peter Island Sunscreen by

Drug Labeling and Warnings

Peter Island Sunscreen by is a Otc medication manufactured, distributed, or labeled by ACCESS BUSINESS GROUP INTERNATIONAL LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Octocrylene 5.0%
Oxybenzone 2.0%
Zinc Oxide 3.9%

WARNINGS

FOR EXTERNAL USE ONLY.
Avoid contact with eyes.Rinse with water if contact occurs.

Discontinue use if signs of rash or irritation develop.

For use on children under 6 moths of age, consult a physician.

Keep out of the reach of children.

Directions

 Apply generously 30 minutes prior to sun exposure. Reapply frequently and after swimming, excessive perspiration and towel drying.

SPL UNCLASSIFIED SECTION

This formula offers broad UVB/UVA protection from the sun's damaging rays and formulated with Zinc Oxide, a naturally sourced sunscreen. Rubs in clear and is non-greasy. Enriched with Aloe Vera and antioxidants Vitamins A,C and E. This moisturizing lotion is dermatologist tested, very water resistant, PABA- free and Frangrance free.

Inactive Ingredients

Water, Ethylhexyl Stearate, Cetyl Dimethicone, Butyloctyl Salicylate, Diisopropyl Adipate, Polyglyceryl-4 Isostearate, Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Beeswax, Isohexadecane, Sodium Chloride, Silica, Hydrogenated Castor Oil, Dimethicone, Disodium EDTA, PEG-8 Dimethicone, Aloe Barbadensis Leaf Juice Powder, Octyldodecanol, Retinyl Palmitate, Tocopheryl Acetate, Ascorbic Acid, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Phenoxyethanol, Methylparaben, Propylparaben.

Principal Display Panel

PETER ISLAND
Sunscreen with ZINC OXIDE
SPF 50
Photostable UVB/UVA Broad Spectrum Protection
DERMATOLOGIST TESTED
Goes on Clear

4 FL OZ(118mL)

INGREDIENTS AND APPEARANCE

PETER ISLAND SUNSCREEN  SPF 50
octocrylene oxybenzone zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10056-700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.9 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5) (UNII: V2W71V8T0X)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
YELLOW WAX (UNII: 2ZA36H0S2V)
ISOHEXADECANE (UNII: 918X1OUF1E)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM (UNII: 7FLD91C86K)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
OCTYLDODECANOL (UNII: 461N1O614Y)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10056-700-13	113 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	11/20/2012

Labeler - ACCESS BUSINESS GROUP INTERNATIONAL LLC (839830713)