Label: NEOSTRATA SHEER PHYSICAL PROTECTION SUNSCREEN BROAD SPECTRUM SPF 50- titanium dioxide and zinc oxide lotion
- NDC Code(s): 58414-0018-1
- Packager: NeoStrata Company Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 31, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients (w/w)
- 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
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Directions
- Shake vigorously for 15 seconds before each use
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply sunscreen at least every 2 hours
- Children under 6 months: Ask a doctor
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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 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-sleeve shirts, pants, hats, and sunglasses
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Inactive ingredients
Water, Dimethicone, Isododecane, C12-15 Alkyl Benzoate, Hydrogenated Polydecene, Butyloctyl Salicylate, Gluconolactone, Styrene/Acrylates Copolymer, Alumina, Ammonium Hydroxide, Lactobionic Acid, PEG-9 Polydimethylsiloxyethyl Dimethicone, Phenethyl Benzoate, Nylon-12, DL-Alpha Tocopheryl Acetate, Epigallocatechin Gallate, Polyhydroxystearic Acid, Ethylhexylglycerin, Tocopherol, Dimethicone/PEG-10/ 15 Crosspolymer, Hydrogen Dimethicone, Isohexadecane, Sodium Citrate, Disteardimonium Hectorite, Magnesium Sulfate, Dipropylene Glycol, Propylene Carbonate, Sodium Bisulfite, Triethoxycaprylylsilane, Phenoxyethanol, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499).
- Other information
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- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
NEOSTRATA SHEER PHYSICAL PROTECTION SUNSCREEN BROAD SPECTRUM SPF 50
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58414-0018 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 70 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 60 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) ISODODECANE (UNII: A8289P68Y2) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GLUCONOLACTONE (UNII: WQ29KQ9POT) ALUMINUM OXIDE (UNII: LMI26O6933) AMMONIA (UNII: 5138Q19F1X) LACTOBIONIC ACID (UNII: 65R938S4DV) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) PHENETHYL BENZOATE (UNII: 0C143929GK) NYLON-12 (UNII: 446U8J075B) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EPIGALLOCATECHIN GALLATE (UNII: BQM438CTEL) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ISOHEXADECANE (UNII: 918X1OUF1E) TOCOPHEROL (UNII: R0ZB2556P8) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) DIPROPYLENE GLYCOL (UNII: E107L85C40) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) PROPYLENE CARBONATE (UNII: 8D08K3S51E) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM BISULFITE (UNII: TZX5469Z6I) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58414-0018-1 1 in 1 CARTON 09/01/2018 1 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 09/01/2018 Labeler - NeoStrata Company Inc. (605754829)
