SUNTONE BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Suntone by

Drug Labeling and Warnings

Suntone by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 3%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only.

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor

INACTIVE INGREDIENT

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Other Information

• protect this product from excesive heat and direct sun

Questions or Comments?

Biocycle Laboratories. Inc.

16363 NW 49 Avenue, Miami, FL 33014

Suntone Broad Spectrum SPF 50 Sunscreen

INGREDIENTS AND APPEARANCE

SUNTONE  BROAD SPECTRUM SPF 50 SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0135
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	27.5 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
TROLAMINE (UNII: 9O3K93S3TK)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
COCOA BUTTER (UNII: 512OYT1CRR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
CARBOMER 940 (UNII: 4Q93RCW27E)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0135-4	177 mL in 1 TUBE; Type 0: Not a Combination Product	03/17/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/17/2014

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0135) , manufacture(58443-0135) , label(58443-0135) , analysis(58443-0135)