PETER ISLAND SUNSCREENSPF 50 SPF 50- homosalate, oxybenzone, octisalate, avobenzone, octocrylene lotion

Peter Island SunscreenSPF 50 by

Drug Labeling and Warnings

Peter Island SunscreenSPF 50 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:

Homosalate 13.0%

Octocrylene 7.0%

Octisalate 5.0%

Oxybenzone 4.0%

Avobenzone 3.0%

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 the age of 6 months consult a physician.

Keep out of reach of children.

DIRECTIONS:

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

OTHER INFORMATION:

• May stain some fabrics
• Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
  

SPL UNCLASSIFIED SECTION

This oil tree formula provides broad spectrum UVA/UVB protection from the sun's damaging rays. It is PABA free, vitamin enriched and very water resistant.

Principal Display Panel

PETER ISLAND

Sunscreen lotion

spf 50

Photostable

Broad Spectrum

UVA/UVB Protection

Very Water Resistant

8 FL.OZ. (237 mL)

INACTIVE INGREDIENTS:

Water, Sorbitol, Stearic Acid,Triethanolamine, Aluminum Starch Octenylsuccinate, Benzyl Alcohol,Sorbitan Isostearate, VP/Eicosene Copolymer, Dimethicone, Polyglyceryl-3 Distearate, Carbomer, Tocopherol, Disodium EDTA, Methylparaben, Propylparaben, Fragrance.

INGREDIENTS AND APPEARANCE

PETER ISLAND SUNSCREENSPF 50   SPF 50
homosalate, oxybenzone, octisalate, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10056-702
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	13 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
DIMETHICONE (UNII: 92RU3N3Y1O)
TOCOPHEROL (UNII: R0ZB2556P8)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10056-702-56	226 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	06/27/2013

Labeler - Access Business Group LLC (839830713)