SUNTONE SUNSCREEN BROAD SPECTRUM SPF 45- avobenzone, 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 1 %, Octisalate 3 %, Octocrylene 0.85 %, and  Oxybezone 1 %

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

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 hour
• children under 6 months: Ask a doctor

Inactive Ingredients

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

PRINCIPAL DISPLAY PANEL - 177 mL  Bottle Label

Suntone

Fit for the Sun

Sunscreen Lotion

Broad Spectrum SPF 8

Water Resistant (80 minutes) 8

Non-Greasy Formula

6 Fl. OZ/ 177mL

INGREDIENTS AND APPEARANCE

SUNTONE  SUNSCREEN BROAD SPECTRUM SPF 45
avobenzone, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	9.94 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8.449 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	9.94 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	29.84 mg  in 1 mL

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

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0103-4	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/28/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/28/2013

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0103) , pack(58443-0103) , manufacture(58443-0103) , analysis(58443-0103)