PREBEL NUDE PROTECT SPF 70 SUNSCREEN- avobenzone, homosalate, octisalate, oxybenzone and octocrylene spray

Prebel by

Drug Labeling and Warnings

Prebel 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 12.5%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 6%

PURPOSE

Sunscreen

INACTIVE INGREDIENT

Diethylhexyl 2,6-Napthalate, Fragrance, Polyester-8, SD Alcohol 40-B, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Uses

*Helps prevent sunburn

WARNINGS

For external use only. When using thi sproduct avoid contact with eyes, if so, rinse with water to remove. Stop use and ask a doctor if irritation or rash occurs. Keep out of reach of children. Flammable, do not use near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 40ºC (104ºF).

Directions

Apply generously to all areas 15 minutes before sun exposure. Spray into hands to apply to face, do not spray directly. Reapply as needed or after towel drying. Ask a doctor before use on children under 6 months of age. Limit sun exposure, wear protective clothing. This product may stain some fabrics.

Nude Protect SPF 70 Sunscreen Spray

INGREDIENTS AND APPEARANCE

PREBEL  NUDE PROTECT SPF 70 SUNSCREEN
avobenzone, homosalate, octisalate, oxybenzone and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0096
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.6 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	106.5 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	42.6 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	23.43 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	51.12 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
DIBUTYL MALEATE (UNII: 4X371TMK9K)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0096-4	177 mL in 1 CAN; Type 0: Not a Combination Product	03/07/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/07/2012

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	manufacture(13630-0096) , analysis(13630-0096)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging Inc.		805987059	pack(13630-0096) , label(13630-0096)