NDC | 36800-722-04 |
Set ID | 5a9c2f6d-1be4-47a8-9825-58f8a6b1ec0b |
Category | HUMAN OTC DRUG LABEL |
Packager | TopCo |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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.
-
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
-
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)