NDC | 11822-1239-3 |
Set ID | 7f7306c2-f970-421c-b01b-153001d278c6 |
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 2.0%.....................................................................................Sunscreen
Homosalate 13%......................................................................................Sunscreen
Octisalate 5.0%........................................................................................Sunscreen
Octocrylene 2.0%.....................................................................................Sunscreen
Oxybenzone 4.0%.....................................................................................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 - OTHER SAFETY INFORMATION
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OIL FREE FACES SUNSCREEN SPF 30 DAYLOGIC
avobenzone 2.00% homosalate 13.00% octisalate 5.00% octocrylene 2.00% oxybenzone 4.00% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1239 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 2 g in 100 mL Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 13 g in 100 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 2 g in 100 mL Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone 4 g in 100 mL Inactive Ingredients Ingredient Name Strength Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) Benzyl Alcohol (UNII: LKG8494WBH) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) Dimethicone (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) Methylparaben (UNII: A2I8C7HI9T) Polyglyceryl-3 Distearate (UNII: ZI1LK470XV) Propylparaben (UNII: Z8IX2SC1OH) Sorbitan Isostearate (UNII: 01S2G2C1E4) Sorbitol (UNII: 506T60A25R) Stearic Acid (UNII: 4ELV7Z65AP) Tocopherol (UNII: R0ZB2556P8) TROLAMINE (UNII: 9O3K93S3TK) EICOSYL POVIDONE (UNII: XQQ9MKE2BJ) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1239-3 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(11822-1239) , label(11822-1239)