Label: SPF 50 MINERAL BASED FACIAL SUNSCREEN- titanium dioxide, zinc oxide cream
- NDC Code(s): 81679-258-50
- Packager: Hutton, Kathleen MD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 25, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- PURPOSE:
-
USES:
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- WARNINGS:
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS:
- Apply liberally 15 minutes before sun exposure.
- Reapply:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- Children under 6 months: Ask a doctor
-
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 value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 am-2 pm
- Wear long-sleeved shirts, pants, hats, and sunglasses
-
INACTIVE INGREDIENTS:
Bismuth Oxychloride, Capric/Caprylic Triglyceride, Caprylhydroxamic Acid, Caprylyl Glycol, Ceteareth-20, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Disodium EDTA, Ethylhexyl Hydroxystearate Benzoate, Glycerin, Iron Oxides, Isododecane, Isohexadecane, Melissa Officinalis (Balm Mint) Extract, Mica, Microcrystalline Wax, Octyldodecyl Neopentanoate,PEG-30 Dipolyhydroxystearate, Sodium Chloride, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Tocopherol, Triethanolamine, Triethoxycaprylylsilane, Water
- OTHER INFORMATION:
- Principal Display Panel – 53 g Bottle Label
-
INGREDIENTS AND APPEARANCE
SPF 50 MINERAL BASED FACIAL SUNSCREEN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81679-258 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 BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE (UNII: 92RU3N3Y1O) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) ETHYLHEXYL HYDROXYSTEARATE BENZOATE (UNII: 3W8F25684B) GLYCERIN (UNII: PDC6A3C0OX) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ISODODECANE (UNII: A8289P68Y2) ISOHEXADECANE (UNII: 918X1OUF1E) MELISSA OFFICINALIS WHOLE (UNII: YF70189L0N) MICA (UNII: V8A1AW0880) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) SODIUM CHLORIDE (UNII: 451W47IQ8X) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TOCOPHEROL (UNII: R0ZB2556P8) TROLAMINE (UNII: 9O3K93S3TK) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81679-258-50 53 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/25/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/25/2024 Labeler - Hutton, Kathleen MD (792310955) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 ANALYSIS(81679-258) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing Inc. (FMI) 793406000 MANUFACTURE(81679-258) , PACK(81679-258)
