NDC | 11822-1214-1 |
Set ID | 8fb6968e-c70a-4f6d-8558-7882d48c511e |
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
Octinoxate 7.5%.......................................................................Sunscreen
Octisalate 5.0%........................................................................Sunscreen
Oxybenzone 6.0%...................................................................Sunscreen
Zinc Oxide 7.0%.......................................................................Sunscreen - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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
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INACTIVE INGREDIENT
Inactive ingredients
Aloe Barbadensis Leaf Extract,
Beeswax, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone,
Cyclopentasiloxane, Cyclohexasiloxane, Diisopropyl Adipate, DMDM
Hydantoin, Ethylhexyl Palmitate, Ethylhexyl Stearate, Glycerin, Hydrated
Silica, Hydrogenated Castor Oil, Polyethylene, Sodium Chloride,
Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate,
Triethoxycaprylylsilane, Water - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FACIAL SUNSCREEN WITH ZINC SPF 50 DAYLOGIC
octinoxate 7.50% octisalate 5.00% oxybenzone 6.00% zinc oxide 7.00% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1214 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate 7.5 g in 100 g Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 g in 100 g Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone 6 g in 100 g Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 7 g in 100 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) YELLOW WAX (UNII: 2ZA36H0S2V) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) Diisopropyl Adipate (UNII: P7E6YFV72X) DMDM HYDANTOIN (UNII: BYR0546TOW) Ethylhexyl Palmitate (UNII: 2865993309) Ethylhexyl Stearate (UNII: EG3PA2K3K5) Glycerin (UNII: PDC6A3C0OX) Hydrated Silica (UNII: Y6O7T4G8P9) Hydrogenated Castor Oil (UNII: ZF94AP8MEY) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) Sodium Chloride (UNII: 451W47IQ8X) COCOA BUTTER (UNII: 512OYT1CRR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Triethoxycaprylylsilane (UNII: LDC331P08E) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1214-1 28.3 g in 1 JAR; Type 0: Not a Combination Product 03/17/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/17/2017 Labeler - Rite Aid (014578892) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(11822-1214) , label(11822-1214)