SUNSHADE DAILY SUN DEFENSE- titanium dioxide, zinc oxide cream
Sunshade Daily Sun Defense by
Drug Labeling and Warnings
Sunshade Daily Sun Defense by is a Otc medication manufactured, distributed, or labeled by BELLAGENA SKINCARE STUDIO & SPA, Custom Analytics LLC, Fragrance Manufacturing INC, Fallien Cosmeceuticals Ltd.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SUNSHADE DAILY SUN DEFENSE
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 85730-258(NDC:58892-258) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 100 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 30 mg in 1 g Inactive Ingredients Ingredient Name Strength TOCOPHEROL (UNII: R0ZB2556P8) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CI 77499 (UNII: XM0M87F357) GLYCERIN (UNII: PDC6A3C0OX) CI 77491 (UNII: 1K09F3G675) CI 77492 (UNII: EX438O2MRT) ISODODECANE (UNII: A8289P68Y2) MICA (UNII: V8A1AW0880) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) ISOHEXADECANE (UNII: 918X1OUF1E) SODIUM CHLORIDE (UNII: 451W47IQ8X) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) WATER (UNII: 059QF0KO0R) ETHYLHEXYL HYDROXYSTEARATE BENZOATE (UNII: 3W8F25684B) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) CYCLOPENTASILOXANE (UNII: 0THT5PCI0R) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CYCLOHEXASILOXANE (UNII: XHK3U310BA) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U) TRIETHANOLAMINE (UNII: 9O3K93S3TK) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) CETEARETH-20 (UNII: YRC528SWUY) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 85730-258-50 53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/09/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 08/09/2023 Labeler - BELLAGENA SKINCARE STUDIO & SPA (114342283) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 analysis(85730-258) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing INC 793406000 manufacture(85730-258) Establishment Name Address ID/FEI Business Operations Fallien Cosmeceuticals Ltd. 958388357 relabel(85730-258)
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