NDC | 11822-1238-3 |
Set ID | 915c35da-51e4-4581-8d7f-0f725bb96673 |
Category | HUMAN OTC DRUG LABEL |
Packager | Rite Aid |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Active ingredients Purpose
- PURPOSE
- INDICATIONS & USAGE
- Warnings
- KEEP OUT OF REACH OF CHILDREN
-
Directions
applyliberally 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
• 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
Behenyl Alcohol
BHT
Butyloctyl Salicylate
Caprylyl Methicone
Dimethicone
Dimethyl Capramide
Disodium EDTA
Ethylhexyl Stearate
Ethylhexylglycerin
Fragrance
Glyceryl Stearate
Hydrated Silica
PEG-100 Stearate
Phenoxyethanol
Polyester-8
Sodium Polyacrylate
Styrene/Acrylate Copolymer
Trideceth-6
Trimethylsiloxysilicate
VP/Hexadecene Copolymer
Water
Xanthan Gum - PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ULTIMATE SHEER SUNSCREEN SPF 30 DAYLOGIC
avobenzone 3.00% homosalate 8.00% octisalate 5.00% octocrylene 4.00% oxybenzone 4.00% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1238 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 8 g in 100 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 4 g in 100 mL Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone 4 g in 100 mL Inactive Ingredients Ingredient Name Strength DOCOSANOL (UNII: 9G1OE216XY) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Butyloctyl Salicylate (UNII: 2EH13UN8D3) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) Dimethicone (UNII: 92RU3N3Y1O) Dimethyl Capramide (UNII: O29Y6X2JEZ) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Ethylhexyl Stearate (UNII: EG3PA2K3K5) Ethylhexylglycerin (UNII: 147D247K3P) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) Hydrated Silica (UNII: Y6O7T4G8P9) PEG-100 Stearate (UNII: YD01N1999R) Phenoxyethanol (UNII: HIE492ZZ3T) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) Trideceth-6 (UNII: 3T5PCR2H0C) Water (UNII: 059QF0KO0R) Xanthan Gum (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1238-3 89 mL in 1 TUBE; Type 0: Not a Combination Product 01/10/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/10/2017 Labeler - Rite Aid (014578892) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(11822-1238) , label(11822-1238)