NDC | 11822-1113-6, 11822-1113-9 |
Set ID | c143c603-ca6a-40f4-999f-a7e360b05f00 |
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 2.00%...............................................................Sunscreen
Homosalate 10.50%..............................................................Sunscreen
Octisalate 5.00%...................................................................Sunscreen
Octocrylene 2.00%................................................................Sunscreen
Oxybenzone 2.00%...............................................................Sunscreen - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- Keep out of reach of children. If product is swallowed, get medicalhelp or contact a Poison Control Center right away
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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 ingredients
Aloe Barbadensis Leaf Juice
Barium Sulfate
Benzyl Alcohol
Carbomer
Cocos Nucifera (Coconut) Oil
Dimethicone
Disodium EDTA
Fragrance
Methylparaben
Mineral Oil
Neopentyl Glycol Diheptanoate
Polyester-7
Polyglyceryl-3 Distearate
Propylparaben
Simmondsia Chinensis (Jojoba) Oil
Sorbitan Isostearate
Sorbitol
Stearic Acid
Tocopherol
Triethanolamine
VP/Eicosene Copolymer
Water - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNSCREEN SPF 30 DAYLOGIC
avobenzone 2.00% homosalate 10.50% octisalate 5.00% octocrylene 2.00% oxybenzone 2.00% lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1113 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone 2 mg in 100 mL Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate 10.5 mg in 100 mL Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate 5 mg in 100 mL Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene 2 mg in 100 mL Oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) Oxybenzone 2 mg in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) Barium Sulfate (UNII: 25BB7EKE2E) Benzyl Alcohol (UNII: LKG8494WBH) CARBOMER 940 (UNII: 4Q93RCW27E) COCONUT OIL (UNII: Q9L0O73W7L) Dimethicone (UNII: 92RU3N3Y1O) EDETATE DISODIUM (UNII: 7FLD91C86K) Methylparaben (UNII: A2I8C7HI9T) Mineral Oil (UNII: T5L8T28FGP) Neopentyl Glycol Diheptanoate (UNII: 5LKW3C543X) Polyester-7 (UNII: 0841698D2F) Polyglyceryl-3 Distearate (UNII: ZI1LK470XV) Propylparaben (UNII: Z8IX2SC1OH) JOJOBA OIL (UNII: 724GKU717M) Sorbitan Isostearate (UNII: 01S2G2C1E4) Sorbitol (UNII: 506T60A25R) Stearic Acid (UNII: 4ELV7Z65AP) Tocopherol (UNII: R0ZB2556P8) TROLAMINE (UNII: 9O3K93S3TK) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1113-6 236 mL in 1 PACKAGE; Type 0: Not a Combination Product 11/30/2016 2 NDC:11822-1113-9 473 mL in 1 PACKAGE; Type 0: Not a Combination Product 11/30/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/30/2016 Labeler - Rite Aid (014578892) Registrant - Product Quest Mfg (927768135) Establishment Name Address ID/FEI Business Operations Product Quest Mfg 927768135 manufacture(11822-1113) , label(11822-1113)