Label: SHEER BROAD SPECTRUM SPF45- zinc oxide, octocrylene, octinoxate, octisalate lotion
- NDC Code(s): 67226-2845-2, 67226-2845-4, 67226-2845-9
- Packager: Vivier Pharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 19, 2023
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- DRUG FACTS
- ACTIVE INGREDIENTS
- USES
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For external use only
• The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects.
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DIRECTIONS
• Apply daily to face, neck and chest.
• Apply liberally and evenly 15 minutes before sun exposure.
• Reapply at least every 2 hours or as needed after towel drying, perspiring heavily or washing.
• For use on children less than 6 months of age, consult a healthcare practitioner.
• Use a water resistant sunscreen if swimming or sweating. - STORAGE AND HANDLING
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INACTIVE INGREDIENTS
BEHENYL ALCOHOL, BUTYLPARABEN, BUTYROSPERMUM PARKII, C12-15 ALKYL BENZOATE, CETEARETH-20, CETEARYL ALCOHOL, CYCLOPENTASILOXANE, CYCLOTETRASILOXANE, ETHYLPARABEN, METHYLPARABEN, PHENOXYETHANOL, PHENYL TRIMETHICONE, PROPYLPARABEN, SILICA, TETRASODIUM EDTA, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, WATER/EAU.
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INGREDIENTS AND APPEARANCE
SHEER BROAD SPECTRUM SPF45
zinc oxide, octocrylene, octinoxate, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67226-2845 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 99 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 80 mg in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) CYCLOMETHICONE 4 (UNII: CZ227117JE) ETHYLPARABEN (UNII: 14255EXE39) METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) DOCOSANOL (UNII: 9G1OE216XY) BUTYLPARABEN (UNII: 3QPI1U3FV8) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PROPYLPARABEN (UNII: Z8IX2SC1OH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) EDETATE SODIUM (UNII: MP1J8420LU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67226-2845-9 1 in 1 CARTON 05/14/2015 09/30/2026 1 90 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:67226-2845-2 250 mL in 1 TUBE; Type 0: Not a Combination Product 05/14/2015 3 NDC:67226-2845-4 1 in 1 CARTON 05/14/2015 06/01/2017 3 4 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 05/14/2015 Labeler - Vivier Pharma Inc. (250996550)
