SPF 30 TROPICAL FLAVOR SUNSCREEN LIP BALM ULTA- avobenzone 2.00% homosalate 15.00% octinoxate 7.50% octisalate 5.00% stick 
Ulta

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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Drug Facts

Active ingredients                                                                          Purpose
Avobenzone 2.00%........................................................................Sunscreen
Octisalate 3.00%............................................................................Sunscreen
Octocrylene 7.00%.........................................................................Sunscreen
Oxybenzone 3.00%........................................................................Sunscreen

Uses • helps prevent sunburn

Warnings
For external use only
Flammable: Do not use near heat, flame, or while smoking.
Do not use on damaged or broken skin
When using this product • Keep out of eyes. Rinse eyes with water to remove.
• Keep away from face to avoid breathing it • Do not puncture or incinerate.
Contents under pressure. Do not store at temperatures above 120ºF.
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 ingredients

Ascorbyl Palmitate
Beeswax
BHT
Cetyl Alcohol
Ethylhexyl Palmitate
Euphorbia Cerifera (Candelilla) Wax
Fragrance
Ozokerite
Paraffin
Polyester-8
Polyethylene
Propylparaben
Retinyl Palmitate
Tocopheryl Acetate

image description

SPF 30 TROPICAL FLAVOR SUNSCREEN LIP BALM  ULTA
avobenzone 2.00% homosalate 15.00% octinoxate 7.50% octisalate 5.00% stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62296-7779
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone2 g  in 100 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate15 g  in 100 g
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Ascorbyl Palmitate (UNII: QN83US2B0N)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Ethylhexyl Palmitate (UNII: 2865993309)  
CANDELILLA WAX (UNII: WL0328HX19)  
CERESIN (UNII: Q1LS2UJO3A)  
PARAFFIN (UNII: I9O0E3H2ZE)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Propylparaben (UNII: Z8IX2SC1OH)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62296-7779-10.14 g in 1 TUBE; Type 0: Not a Combination Product01/27/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/27/201610/10/2017
Labeler - Ulta (608168597)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(62296-7779) , label(62296-7779)

Revised: 10/2017
 
Ulta