PETER ISLAND SUNSCREEN SPF 30- homosalate, oxybenzone, octisalate, avobenzone, octocrylene 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 LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Homosalate 10.0%

Octisalate 5.0%

Avobenzone 2.0%

Octocrylene 2.0%

Oxybenzone 2.0%

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 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 30

Photostable

Broad Spectrum

UVA/UVB Protection

Very Water Resistant

8 FL.OZ. (237 mL)

INACTIVE INGREDIENTS:

Water, Sorbitan Isostearate, Sorbitol, Polyglyceryl-3 Distearate, Triethanolamine, Stearic Acid, VP/Eicosene Copolymer, Benzyl Alcohol, Dimethicone, Barium Sulfate, Carbomer, Simmondsia Chinensis (jojoba) Seed Oil, Tocopherol, Mineral Oil, Disodium EDTA, Aloe Barbadensis Leaf Juice, Octadecene/MA Co polymer, MethylParaben, Propylparaben, Fragrance.

INGREDIENTS AND APPEARANCE

PETER ISLAND SUNSCREEN  SPF 30
homosalate, oxybenzone, octisalate, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10056-705
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
SORBITOL (UNII: 506T60A25R)
TROLAMINE (UNII: 9O3K93S3TK)
STEARIC ACID (UNII: 4ELV7Z65AP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIMETHICONE (UNII: 92RU3N3Y1O)
BARIUM SULFATE (UNII: 25BB7EKE2E)
JOJOBA OIL (UNII: 724GKU717M)
TOCOPHEROL (UNII: R0ZB2556P8)
MINERAL OIL (UNII: T5L8T28FGP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10056-705-56	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	06/28/2013

Labeler - Access Business Group LLC (839830713)