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

Ultimate Sheer SPF 55 body by

Drug Labeling and Warnings

Ultimate Sheer SPF 55 body by is a Otc medication manufactured, distributed, or labeled by TopCo, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients Purpose
Avobenzone 3.00%, Homosalate 15.00%,
Octisalate 5.00%, Octocrylene 2.75%,
Oxybenzone 6.00%.

PURPOSE

Sunscreen

INDICATIONS & USAGE

Uses helps prevent sunburn

WARNINGS

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 INGREDIENT

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 SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-722
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	3 g  in 100 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	15 g  in 100 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	5 g  in 100 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	2.75 g  in 100 g
Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	Oxybenzone	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-722-04	141 g in 1 CAN; Type 0: Not a Combination Product	12/13/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/13/2012

Labeler - TopCo (006935977)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(36800-722) , label(36800-722)