PETER ISLAND SUNSCREEN SPF 70- homosalate, oxybenzone, octisalate, avobenzone, octocrylene lotion
AMWAY CORP.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

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.

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50390-704
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
TRICAPRIN (UNII: O1PB8EU98M)
TOCOPHEROL (UNII: R0ZB2556P8)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50390-704-56	226 g in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/26/2012

Labeler - AMWAY CORP. (083416854)