Label: MOISTURE RESTORE DAY PROTECTIVE MATTEFYING BROAD SPECTRUM SPF15 COMBINATION TO OILY- octinoxate, octisalate, and titanium dioxide lotion
- NDC Code(s): 62839-0272-7
- Packager: NSE Products, 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 January 13, 2022
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
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Uses
- Helps prevent sunburn. Higher SPF gives more sunburn protection
- 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.
- Warning
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Directions
- Using fingertips, apply generously to clean face and neck in an upward, outward motion. Use every morning before makeup application.
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Sunprotection 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. -2p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
- Apply liberally 15 minutes before sun exposure
- Use a water resistant sunscreen if swimming or sweating
- Reapply at least every 2 hours
- Children under 6 months: Ask a doctor.
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Inactive Ingredients
Water (Aqua), Butylene Glycol, Polymethyl Methacrylate, Polysorbate 40, Microcrystalline Cellulose, Corn Starch Modified, Sorbitan Oleate, Glycerin, Potassium Cetyl Phosphate, Dunaliella Salina Extract, Sodium Hyaluronate, Biosaccharide Gum-1, Glyceryl Stearate, PEG-100 Stearate, Silica, Cyclopentasiloxane, Cetyl Alcohol, Dimethicone, Hydrogenated Polydecene, Cyclohexasiloxane, PEG/PPG-18/18 Dimethicone, Xanthan Gum, Cellulose Gum, Disodium EDTA, Phytic Acid, Aminomethyl Propanol, Fragrance (Parfum), Phenoxyethanol, Chlorphenesin, Benzoic Acid.
- Other Information
- Questions?
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton
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INGREDIENTS AND APPEARANCE
MOISTURE RESTORE DAY PROTECTIVE MATTEFYING BROAD SPECTRUM SPF15 COMBINATION TO OILY
octinoxate, octisalate, and titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62839-0272 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 75 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 30 mg in 1 mL Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 28 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Butylene Glycol (UNII: 3XUS85K0RA) Polysorbate 40 (UNII: STI11B5A2X) Microcrystalline Cellulose (UNII: OP1R32D61U) Glycerin (UNII: PDC6A3C0OX) Sorbitan Monooleate (UNII: 06XEA2VD56) Potassium Cetyl Phosphate (UNII: 03KCY6P7UT) Dunaliella Salina (UNII: F4O1DKI9A6) Hyaluronate Sodium (UNII: YSE9PPT4TH) Biosaccharide Gum-1 (UNII: BB4PU4V09H) Glyceryl Monostearate (UNII: 230OU9XXE4) PEG-100 Stearate (UNII: YD01N1999R) Silicon Dioxide (UNII: ETJ7Z6XBU4) Cyclomethicone 5 (UNII: 0THT5PCI0R) Cetyl Alcohol (UNII: 936JST6JCN) Dimethicone (UNII: 92RU3N3Y1O) HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7) Cyclomethicone 6 (UNII: XHK3U310BA) Xanthan Gum (UNII: TTV12P4NEE) Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311) Edetate Disodium (UNII: 7FLD91C86K) Fytic Acid (UNII: 7IGF0S7R8I) Aminomethylpropanol (UNII: LU49E6626Q) Phenoxyethanol (UNII: HIE492ZZ3T) Chlorphenesin (UNII: I670DAL4SZ) Benzoic Acid (UNII: 8SKN0B0MIM) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62839-0272-7 1 in 1 CARTON 06/10/2001 1 50 mL in 1 BOTTLE, PUMP; 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 06/10/2001 Labeler - NSE Products, Inc. (803486393)