ULTIMATE SHEER SPF 55 BODY- avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 2.75% oxybenzone 6.00% spray 
TopCo

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 3.00%, Homosalate 15.00%,
Octisalate 5.00%, Octocrylene 2.75%,
Oxybenzone 6.00%.

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


• spray liberally and spread evenly by hand 15 minutes before sun exposure
• reapply: • after 80 minutes of swimming or sweating
• immediately after towel drying • at least every 2 hours
• 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 a well-ventilated area
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

Acrylates Dimethicone Copolymer,
Acrylates/Octylacrylamide Copolymer, Alcohol Denat., Ascorbyl Palmitate,
Cyclopentasiloxane, Dimethicone, Fragrance,
Polyester-8, PPG-5-Ceteth-20, Retinyl Palmitate,
Tocopheryl Acetate, Trisiloxane.

Other information • protect this product from excessive heat and direct sun • may stain fabrics

image description

ULTIMATE SHEER SPF 55 BODY 
avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 2.75% oxybenzone 6.00% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-722
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone3 g  in 100 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate15 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene2.75 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Alcohol (UNII: 3K9958V90M)  
Ascorbyl Palmitate (UNII: QN83US2B0N)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
PPG-5-Ceteth-20 (UNII: 4AAN25P8P4)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Trisiloxane (UNII: 9G1ZW13R0G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-722-04141 g in 1 CAN; Type 0: Not a Combination Product12/13/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/13/2012
Labeler - TopCo (006935977)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(36800-722) , label(36800-722)

Revised: 7/2018
Document Id: ade38f06-0008-4d35-acaf-f812b2e3b790
Set id: 5a9c2f6d-1be4-47a8-9825-58f8a6b1ec0b
Version: 1
Effective Time: 20180713
 
TopCo