Label: SUNSCREEN SPF 30 DAYLOGIC- avobenzone 2.00% homosalate 10.50% octisalate 5.00% octocrylene 2.00% oxybenzone 2.00% lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 11822-1113-6, 11822-1113-9 - 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 14, 2018
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- Official Label (Printer Friendly)
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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)
