Label: SAND CLOUD MINERAL SUNSCREEN- titanium dioxide and zinc oxide lotion
- NDC Code(s): 83081-2045-3, 83081-2045-5
- Packager: Sand Cloud Holdings, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 6, 2023
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
- shake well prior to use
- apply liberally 15 minutes before sun exposure
- children under 6 months of age: 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 a.m.- 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- reapply :
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Other information
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Inactive ingredients
Alumina, Aluminum Stearate, Beeswax, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Dimethicone, Disodium EDTA, Ethylhexyl Palmitate, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Oil, Methyl Glucose Dioleate, Octyldodecyl Neopentanoate, PEG-7 Hydrogenated Castor Oil, Phenoxyethanol, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Propanediol, Purified Water, Sorbitan Oleate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethoxycaprylylsilane, Trimethylsiloxysilicate, VP Hexadecene Copolymer
- Questions?
- Sand Cloud Mineral Sunscreen 3oz
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INGREDIENTS AND APPEARANCE
SAND CLOUD MINERAL SUNSCREEN
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83081-2045 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 54 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 108 mg in 1 mL Inactive Ingredients Ingredient Name Strength ETHYLHEXYL PALMITATE (UNII: 2865993309) ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5) CAPRYLYL GLYCOL (UNII: 00YIU5438U) HEXYL LAURATE (UNII: 4CG9F9W01Q) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P) CHLORPHENESIN (UNII: I670DAL4SZ) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) PEG-7 HYDROGENATED CASTOR OIL (UNII: WE09129TH5) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPANEDIOL (UNII: 5965N8W85T) WATER (UNII: 059QF0KO0R) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU) DIMETHICONE (UNII: 92RU3N3Y1O) TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ALUMINUM STEARATE (UNII: U6XF9NP8HM) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) ALUMINUM OXIDE (UNII: LMI26O6933) YELLOW WAX (UNII: 2ZA36H0S2V) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83081-2045-3 89 mL in 1 TUBE; Type 0: Not a Combination Product 06/30/2023 2 NDC:83081-2045-5 148 mL in 1 TUBE; Type 0: Not a Combination Product 06/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 06/30/2023 Labeler - Sand Cloud Holdings, LLC (042484924)
