Label: ULTIMATE SHEER SPF 55 BODY- avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 2.75% oxybenzone 6.00% spray
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Contains inactivated NDC Code(s)
NDC Code(s): 36800-722-04 - Packager: TopCo
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated July 13, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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.
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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
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ULTIMATE SHEER SPF 55 BODY
avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 2.75% oxybenzone 6.00% sprayProduct 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)
