NDC | 11822-1111-3 |
Set ID | 4c761bf4-8542-4f8d-a04a-68f9dd2382e2 |
Category | HUMAN OTC DRUG LABEL |
Packager | Ride 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 4.50%................................................................Sunscreen
Oxybenzone 6.00%...............................................................Sunscreen - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions • apply liberally 15 minutes before sun exposure
• reapply: • after 80 minutes of swimming or sweating
• immediately after towel drying • at least every 2 hours
• 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/C10-30 Alkyl Acrylate
Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer,
Acrylates/ Dimethicone Copolymer, Beeswax, BHT,
Butyloctyl Salicylate, Cyclopentasiloxane, Dimethyl
Capramide, Dipotassium Glycyrrhizate, Disodium
EDTA, Ethylhexylglycerin, Fragrance, Glyceryl
Stearate, Methylisothiazolinone, PEG-100 Stearate,
Polyester-8, Silica, Styrene/ Acrylates Copolymer,
Triethanolamine, Water.
May Also Contain Benzisothiazoline, Chlorphenesin - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ULTIMATE SHEER SUNSCREEN SPF 85 RITE AID
avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 4.50% oxybenzone 6.00% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1111 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 3.00 g in 100 mL Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 15.00 g in 100 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5.00 g in 100 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 4.50 g in 100 mL Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone 6.00 g in 100 mL Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) YELLOW WAX (UNII: 2ZA36H0S2V) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Butyloctyl Salicylate (UNII: 2EH13UN8D3) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) Dimethyl Capramide (UNII: O29Y6X2JEZ) GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX) EDETATE DISODIUM (UNII: 7FLD91C86K) Ethylhexylglycerin (UNII: 147D247K3P) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Methylisothiazolinone (UNII: 229D0E1QFA) PEG-100 Stearate (UNII: YD01N1999R) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) TROLAMINE (UNII: 9O3K93S3TK) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1111-3 89 mL in 1 TUBE; Type 0: Not a Combination Product 01/20/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/20/2014 Labeler - Ride Aid (014578892) Establishment Name Address ID/FEI Business Operations Product Quest Mfg. 927768135 manufacture(11822-1111) , label(11822-1111)