ULTA BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray 
Prime Packaging, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients

Avobenzone 3 %, Homosalate 7.5 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 2 %

Purpose

Sunscreen

Uses

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

Inactive Ingredients

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

Other information

Questions or Comments?

Call toll free 1-866-983-8582

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

SUNCARE

BROAD

SPECTRUM

SPF 30

WATER RESISTANT

(80 MINUTES)

OIL-FREE

CONTINUOUS SPRAY

SUNSCREEN

ULTA

6 fl. oz/177 mL

ULTA  BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13630-0069
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE16.3 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE22.4 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE22.4 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE22.4 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40.8 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
ALCOHOL (UNII: 3K9958V90M)  
DIBUTYL MALEATE (UNII: 4X371TMK9K)  
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13630-0069-4177 mL in 1 CAN; Type 0: Not a Combination Product12/17/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35212/17/2003
Labeler - Prime Packaging, Inc. (805987059)
Registrant - Prime Packaging, Inc. (805987059)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028manufacture(13630-0069) , analysis(13630-0069)
Establishment
NameAddressID/FEIBusiness Operations
Prime Packaging, Inc.805987059label(13630-0069) , pack(13630-0069)

Revised: 1/2020
Document Id: 9c5cfd42-ea48-3ce7-e053-2995a90ae313
Set id: 0257edbf-1f24-4377-bd9c-e53218803ec5
Version: 3
Effective Time: 20200117
 
Prime Packaging, Inc.