Label: ULTIMATE SHEER SUNSCREEN SPF 85 RITE AID- avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 4.50% oxybenzone 6.00% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-1111-3 - Packager: Ride 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
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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)
