ULTA BROAD SPECTRUM SPF 15- avobenzone, octisalate and octocrylene spray

Ulta by

Drug Labeling and Warnings

Ulta 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 2 %, Octisalate 5 %, Octocrylene 1.85 %

PURPOSE

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 broken or damaged skin

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

• keep away from face to avoid breathing it
• contents under pressure - do not puncture or incinirate. Do not store at temperatures above 120 0F

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

• spray liberally and spread evenly by hand 15 minutes before sun exposure
• hold container 4 to 6 inches from the skin to apply
• do not spray directly into face. Spray on hands then apply to face
• do not apply in windy conditions
• use in well-ventilated areas
• 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 Ingredients

Aloe Barbadensis Leaf Juice, Diethylhexyl 2,6-Naphthalate, Fragrance (Parfum), Polyester-8, SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other information

• protect this product from excesive heat and direct sun
• avoid spraying on fabrics - could cause discoloration

QUESTIONS

Questions or Comments?

Call toll free 1-866-983-8582

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

SUNCARE

BROAD

SPECTRUM

SPF 15

WATER RESISTANT

(80 MINUTES)

OIL-FREE

CONTINUOUS SPRAY

SUNSCREEN

ULTA

6 Fl. Oz/177 mL

INGREDIENTS AND APPEARANCE

ULTA  BROAD SPECTRUM SPF 15
avobenzone, octisalate and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0068
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	16.2 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	14.9 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ALCOHOL (UNII: 3K9958V90M)
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: 13630-0068-4	177 mL in 1 CAN; Type 0: Not a Combination Product	12/17/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/17/2013

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(13630-0068) , analysis(13630-0068)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	label(13630-0068) , pack(13630-0068)