NDC | 11822-1217-3, 11822-1217-5, 11822-1217-6 |
Set ID | 8bd88ee8-4683-432c-b141-eb92ff4b9580 |
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 3.0%.........................................................................Sunscreen
Homosalate 10.0%........................................................................Sunscreen
Octisalate 5.0%............................................................................Sunscreen
Octocrylene 2.0%..........................................................................Sunscreen
Oxybenzone 4.0%.........................................................................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
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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 INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUNSCREEN SPF 30 DAYLOGIC
avobenzone 3% homosalate 10% octisalate 5% octocrylene 2% oxybenzone 4% sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1217 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 10 g in 100 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 g Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 2 g in 100 g Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone 4 g in 100 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Diethylhexyl Syringylidenemalonate (UNII: 3V5U97P248) Glycerin (UNII: PDC6A3C0OX) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) Stearoxytrimethylsilane (UNII: 9862TW94B2) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1217-3 85 g in 1 CAN; Type 0: Not a Combination Product 01/31/2018 2 NDC:11822-1217-5 170 g in 1 CAN; Type 0: Not a Combination Product 01/31/2018 3 NDC:11822-1217-6 203 g in 1 PACKAGE; Type 0: Not a Combination Product 01/31/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/31/2018 Labeler - Rite Aid (014578892) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(11822-1217) , label(11822-1217)