PETER ISLAND SUNSCREEN SPF 70- 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 15.0%

Octocrylene 10.0%

Oxybenzone 6.0%

Octisalate 5.0%

Avobenzone 3.0%

WARNING:

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 vitamin enriched formula is very water resistant, fragrance free, PABA free and provides Broad Spectrum UVA/UVB protection.

Principal Display Panel

PETER ISLAND

Sunscreen lotion

spf 70

Photostable

Broad Spectrum

UVA/UVB Protection

Very Water Resistant

8 FL.OZ. (237 mL)

INACTIVE INGREDIENTS:

Water, Glyceryl Stearate, Microcrystalline Cellulose, Butylene Glycol, PEG-100 Stearate, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Benzyl Alcohol, Diethylhexyl Syringylidenemalonate, Behenyl Alcohol, Butylated PVP, Palmitic Acid, Stearic Acid, C12-16 Alcohols, Cellulose Gum, Caprylic/Capric Triglyceride, Lecithin, Retinyl Palmitate, Tocopherol, Sodium Ascorbyl Phosphate, Disodium EDTA, Chlorphenesin.

INGREDIENTS AND APPEARANCE

PETER ISLAND SUNSCREEN  SPF 70
homosalate, oxybenzone, octisalate, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10056-704
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 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	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
DOCOSANOL (UNII: 9G1OE216XY)
PALMITIC ACID (UNII: 2V16EO95H1)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
CETYL ALCOHOL (UNII: 936JST6JCN)
LAURYL ALCOHOL (UNII: 178A96NLP2)
CHLORPHENESIN (UNII: I670DAL4SZ)
PEG-100 STEARATE (UNII: YD01N1999R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TRICAPRIN (UNII: O1PB8EU98M)
TOCOPHEROL (UNII: R0ZB2556P8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10056-704-56	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)