NDC | 11822-7778-4 |
Set ID | 40112c8b-718f-4ea1-8324-9eff26798ab2 |
Category | HUMAN OTC DRUG LABEL |
Packager | Rite Aid |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
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ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 3.00%........................................................................Sunscreen
Homosalate 15.00%.......................................................................Sunscreen
Octisalate 5.00%............................................................................Sunscreen
Octocrylene 10.00%........................................................................Sunscreen
Oxybenzone 6.00%.........................................................................Sunscreen - 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. If product is swallowed, get medical help or
contact a Poison Control Center right away -
DOSAGE & ADMINISTRATION
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ULIMATE SHEER SPF 85 RITE AID
avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% oxybenzone 6.00% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-7778 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 10 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) Butyloctyl Salicylate (UNII: 2EH13UN8D3) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-7778-4 141 g in 1 CAN; Type 0: Not a Combination Product 02/21/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/21/2013 Labeler - Rite Aid (014578892) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(11822-7778) , label(11822-7778)