Label: THE DAY FORMULA BROAD SPECTRUM SPF 30 SUNSCREEN- titanium dioxide cream
- NDC Code(s): 80518-123-01
- Packager: Dar Companies, LLC
- Category: HUMAN OTC DRUG LABEL
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 May 11, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours
- Use water resistant sunscreen if swimming or sweating.
- Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10am - 2pm. Wear long sleeved shirts, pants, hats and sunglasses.
- Children under 6, ask a doctor.
- Other Information
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Inactive Ingredients
Water, C12-15 Alkyl Benzoate, Propanediol, Benzotriazolyl Dodecyl p-Cresol, Butylene Glycol, Butyloctyl Salicylate, Niacinamide, Polymethylsilsesquioxane, Silica, Aluminum Stearate, Polyhydroxystearic Acid, 1,2-Hexanediol, Pentylene Glycol, Caprylic/Capric Triglyceride, Alumina, Ammonium Acryloyldimethyltaurate/VP Copolymer, Polyacrylate Crosspolymer-6, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Sodium Stearoyl Glutamate, Octyldodecanol, Polyisobutene, Hydroxypropyl Methylcellulose Stearoxy Ether, Stearic Acid, Ethylhexylglycerin, Xantham Gum, Echium Plantagineum Seed Oil, Sorbitan Oleate, Caprylic/Capryl Glucoside, t-Butyl Alcohol, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Tocopherol
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 35 ML Bottle Carton
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INGREDIENTS AND APPEARANCE
THE DAY FORMULA BROAD SPECTRUM SPF 30 SUNSCREEN
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80518-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 88 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) Propanediol (UNII: 5965N8W85T) BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) NIACINAMIDE (UNII: 25X51I8RD4) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ALUMINUM STEARATE (UNII: U6XF9NP8HM) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALUMINUM OXIDE (UNII: LMI26O6933) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) OCTYLDODECANOL (UNII: 461N1O614Y) STEARIC ACID (UNII: 4ELV7Z65AP) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) XANTHAN GUM (UNII: TTV12P4NEE) ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) SUNFLOWER OIL UNSAPONIFIABLES (UNII: T7ZE2WA4MB) TOCOPHEROL (UNII: R0ZB2556P8) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) PENTYLENE GLYCOL (UNII: 50C1307PZG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80518-123-01 1 in 1 CARTON 09/01/2022 1 30 mL in 1 BOTTLE; 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 09/01/2022 Labeler - Dar Companies, LLC (117641085)