CONCEPT II SOLSCENTS BROAD SPECTRUM SPF 15 PINA COLADA- avobenzone, octisalate, and octocrylene lotion

Concept II by

Drug Labeling and Warnings

Concept II 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 2%

Octisalate 5% Octocrylene 1.85%

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 a 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, Allantoin, 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, Sorbitol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua).

Other Information

• protect this product from excesive heat and direct sun.

Questions or comments?

SolScents, LLC. 2200 N.W. 92nd Avenue. Miami, Florida 33172

Concept II SolScents Broad Spectrum SPF 15 Pina Colada

INGREDIENTS AND APPEARANCE

CONCEPT II  SOLSCENTS BROAD SPECTRUM SPF 15 PINA COLADA
avobenzone, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0215
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	18.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
COCOA BUTTER (UNII: 512OYT1CRR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SORBITOL (UNII: 506T60A25R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
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)
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALLANTOIN (UNII: 344S277G0Z)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0215-4	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/20/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	05/20/2013

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0215) , manufacture(58443-0215) , label(58443-0215)