ESSENTIAL MINERAL SUN PROTECTION- titanium dioxide, zinc oxide cream
Essential Mineral Sun Protection by
Drug Labeling and Warnings
Essential Mineral Sun Protection by is a Otc medication manufactured, distributed, or labeled by Fern Burg, 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
ESSENTIAL MINERAL SUN PROTECTION
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC: 85387-258(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 CI 77491 (UNII: 1K09F3G675) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) TOCOPHEROL (UNII: R0ZB2556P8) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ETHYLHEXYL HYDROXYSTEARATE BENZOATE (UNII: 3W8F25684B) CYCLOHEXASILOXANE (UNII: XHK3U310BA) ISOHEXADECANE (UNII: 918X1OUF1E) ISODODECANE (UNII: A8289P68Y2) CI 77492 (UNII: EX438O2MRT) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CI 77499 (UNII: XM0M87F357) SODIUM CHLORIDE (UNII: 451W47IQ8X) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TRIETHANOLAMINE (UNII: 9O3K93S3TK) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) MICA (UNII: V8A1AW0880) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CYCLOPENTASILOXANE (UNII: 0THT5PCI0R) CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U) CETEARETH-20 (UNII: YRC528SWUY) MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO) BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 85387-258-50 53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/13/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/13/2023 Labeler - Fern Burg (042907660) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 analysis(85387-258) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing Inc. 793406000 manufacture(85387-258) Establishment Name Address ID/FEI Business Operations Fallien Cosmeceuticals Ltd. 958388357 relabel(85387-258)
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