FAIR AND SQUARE KIDS BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, and oxybenzone aerosol, spray

Fair and Square by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5 %, and Oxybenzone 6 %

Purpose

Sunscreen

Uses

• helps prevent sunburn
• If use as directed with other sun protection measures (see Directions), decreases the risk of skin cancer & 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. Keep away from face to avoid breathing it. Content is under pressure - do not pumcture or incinerate. Do not store at temperature above 120°F.

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.

Flammable: Do not use near heat, flame or while smoking.

Directions

• Hold container 4 to 6 inches from the skin & spray to apply. Spread evenly by hand 15 minutes before sun exposure
• DO NOT spray directly into face. Spray on hands then apply to face.
• Do not apply in windy conditions.
• Use in a well ventilated area

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 & early aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and othre sun protection measures including:

• limit time in the sun, especially from 10am - 2 pm
• wear long-sleeve shirts, pants, hats, and sunglasses

Children under 6 months: Ask a doctor

Inactive ingredients

Fragrance (Parfum), SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other Information

• Protect this product from exessive heat and direct sunlight
• avoid spraying on fabrics - could cause discoloration

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

Fair

&

Square

Kids

Sunscreen

Continuous Spray wirh

Light Scent

50

Broad Spectrum

SPF 50

UVA/UVB Protection

Water Resistant (80 Minutes)

Oil-Free, Non-Greasy Formula

Compare to Coppertone

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

FAIR AND SQUARE  KIDS BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, and oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0082
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	24.7 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	123.6 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	41.2 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	49.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
BUTYL MALEURATE (UNII: 6FUA0H660I)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0082-4	177 mL in 1 CAN; Type 0: Not a Combination Product	02/28/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/28/2014

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(13630-0082) , analysis(13630-0082)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	label(13630-0082) , pack(13630-0082)