SUNPLUS SPF50 FACE BODY SUNSCREEN- sunscreen lotion

Sunplus SPF50 Face Body Sunscreen by

Drug Labeling and Warnings

Sunplus SPF50 Face Body Sunscreen by is a Otc medication manufactured, distributed, or labeled by I.Shay Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Homosalate- 15%

Octocrylene- 6%

Octisalate- 5%

Avobenzone- 2%

PURPOSE

Sunscreen

KEEP OUT OF REACH OF CHILDREN

WARNING - Keep out of reach of children

INDICATIONS & USAGE

Helps prevent sunburn and photodamage.

If used as directed with other sun protection measures, decreases the risk of skin cancer and early aging caused by the sun.

INACTIVE INGREDIENT

Purified Water, Glycerin, Ceteareth-20, Cetearyl Alcohol, Dimethicone, Glyceryl stearate, PEG-100, Acrylic Polymer, Cetyl Alcohol, Potassium Hexadecyl Phosphate, PEG 300, Grapeseed Oil, Sunflower Oil, Safflower Oil, Organic Borage Oil, Organic Evening Primrose Oil, Allantoin, Hyaluronic Acid, Organic Raspberry Seed Oil, Organic Jojoba Oil, Organic Aloe Oil, Phenoxyethanol, Ethylhexylglycerin

WARNINGS

For external use only. Do not use on damaged or broken skin. When using this product keep out f eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation occurs. If swallowed get medical help or contact Poison Control Center. Keep out of reach of children.

DOSAGE & ADMINISTRATION

Apply liberally to dry skin 15 minutes before sun exposure. Reapply to dry skin after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours. Children under 6 months ask a doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNPLUS SPF50 FACE BODY SUNSCREEN 
sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65112-304
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.06 g  in 118 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 118 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.15 g  in 118 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.02 g  in 118 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65112-304-01	118 mL in 1 TUBE; Type 0: Not a Combination Product	06/01/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/01/2004

Labeler - I.Shay Cosmetics (151582384)