PETER ISLAND KIDS SUNSCREEN SPF 65- homosalate, oxybenzone, octisalate, avobenzone, octocrylene lotion

Peter Island Kids Sunscreen by

Drug Labeling and Warnings

Peter Island Kids Sunscreen by is a Otc medication manufactured, distributed, or labeled by AMWAY CORP.. 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
kids Sunscreen lotion
spf 65
Vitamin Enriched
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 KIDS SUNSCREEN  SPF 65
homosalate, oxybenzone, octisalate, avobenzone, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50390-703
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)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
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)
TOCOPHEROL (UNII: R0ZB2556P8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TRICAPRIN (UNII: O1PB8EU98M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50390-703-56	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	11/26/2012

Labeler - AMWAY CORP. (083416854)