Label: ULTIMATE SHEER SUNSCREEN SPF 100 RITE AID- avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% oxybenzone 6.00% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-1112-3 - Packager: Rite Aid
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 October 24, 2017
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- Official Label (Printer Friendly)
- Active ingredients Purpose
- PURPOSE
- Uses
- WarningsFor external use only
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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 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 month: Ask a doctor -
Inactive ingredients
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Acrylates/Dimethicone Copolymer, Beeswax, BHT, Butyloctyl Salicylate, Chlorphenesin, Cyclopentasiloxane, Dimethyl Capramide, Dipotassium Glycyrrhizate, Disodium EDTA, Ethylhexylglycerin, Fragrance, Glyceryl Stearate, Methylisothiazolinone, PEG-100 Stearate, Polyester-8, Silica, Styrene/Acrylates Copolymer, Triethanolamine, Water
- Other information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ULTIMATE SHEER SUNSCREEN SPF 100 RITE AID
avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 10.00% oxybenzone 6.00% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1112 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 mL Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 15 g in 100 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 10 g in 100 mL Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone 6 g in 100 mL Inactive Ingredients Ingredient Name Strength YELLOW WAX (UNII: 2ZA36H0S2V) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Butyloctyl Salicylate (UNII: 2EH13UN8D3) Chlorphenesin (UNII: I670DAL4SZ) 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) TROLAMINE (UNII: 9O3K93S3TK) Water (UNII: 059QF0KO0R) CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36) BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P) METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1112-3 89 mL in 1 TUBE; Type 0: Not a Combination Product 05/25/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/25/2012 Labeler - Rite Aid (014578892) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(11822-1112) , label(11822-1112)
