Label: FACIAL SUNSCREEN WITH ZINC SPF 50 DAYLOGIC- octinoxate 7.50% octisalate 5.00% oxybenzone 6.00% zinc oxide 7.00% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-1214-1 - 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 May 11, 2018
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- Official Label (Printer Friendly)
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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)
