Label: CHARLOTTE TILBURY BROAD SPECTRUM SPF 50 SUNSCREEN INVISIBLE UV FLAWLESS PRIMER- avobenzone, octinoxate, octisalate, octocrylene cream
- NDC Code(s): 70186-700-01
- Packager: Charlotte Tilbury Beauty Ltd.
- 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 May 11, 2022
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- Official Label (Printer Friendly)
- DRUG FACTS Active ingredients
- Purpose
- Uses
- Warnings
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Directions
- apply liberally and evenly 15 minutes before sun exposure
- children under 6 months of age: ask a doctor
- reapply at least every 2 hours
- use a water-resistant sunscreen if swimming or sweating:
- immediately after towel drying
- at least every 2 hours
- 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 - 2pm
- wear long-sleeved shirts, pants, hats, and sunglasses
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Inactive ingredients
Water, Butylene Glycol, Diethylhexyl Succinate, Glycerin, Dextrin Palmitate, Pentylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, PEG-60 Glyceryl Isostearate, Marrubium Vulgare Extract, Titanium Dioxide (CI 77891), Polyglyceryl-2 Triisostearate, Talc, Hydroxypropyl Methylcellulose Stearoxy Ether, Polysorbate 60, Sorbitan Isostearate, Agar, Tocopherol, Xanthan Gum, Iron Oxides (CI 77492), Isopropyl Titanium Triisostearate, Aluminum Hydroxide, Sodium Hyaluronate, Iron Oxides (CI 77491), Khaya Senegalensis Bark Extract, Maltodextrin, Citric Acid, BHT, Ascorbyl Glucoside, Camellia Oleifera Seed Oil, Butyrospermum Parkii (Shea) Butter, Rosa Canina Fruit Oil, Sodium Hydroxide, Iron Oxides (CI 77499), Plumeria Alba Flower Extract, Potassium Sorbate, Sodium Benzoate, Aloe Barbadensis Leaf Extract, Solanum Tuberosum (Potato) Pulp Extract, Ascorbyl Dipalmitate.
- Other information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHARLOTTE TILBURY BROAD SPECTRUM SPF 50 SUNSCREEN INVISIBLE UV FLAWLESS PRIMER
avobenzone, octinoxate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70186-700 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.038 g in 30 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.918 g in 30 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 1.377 g in 30 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 0.612 g in 30 mL Inactive Ingredients Ingredient Name Strength DEXTRIN PALMITATE (CORN; 20000 MW) (UNII: 89B2BSF9I3) PHENOXYETHANOL (UNII: HIE492ZZ3T) PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) TALC (UNII: 7SEV7J4R1U) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8) AGAR (UNII: 89T13OHQ2B) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM HYDROXIDE (UNII: 55X04QC32I) FERROSOFERRIC OXIDE (UNII: XM0M87F357) HYPROMELLOSE 2910 0.45% STEAROXY ETHER (UNII: HG3GR8HU7X) MALTODEXTRIN (UNII: 7CVR7L4A2D) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) HYALURONATE SODIUM (UNII: YSE9PPT4TH) FERRIC OXIDE RED (UNII: 1K09F3G675) SODIUM BENZOATE (UNII: OJ245FE5EU) ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) ASCORBYL DIPALMITATE (UNII: 624RX3IESR) HOREHOUND (UNII: K08036XEJV) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYGLYCERYL-2 TRIISOSTEARATE (UNII: 68DUY2D39A) PLUMERIA ALBA FLOWER (UNII: LGC8P2PC4H) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ALOE VERA LEAF (UNII: ZY81Z83H0X) POTATO PULP (UNII: 844I2DX0IS) PENTYLENE GLYCOL (UNII: 50C1307PZG) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) WATER (UNII: 059QF0KO0R) CAMELLIA OIL (UNII: T1PE06G0VE) SHEA BUTTER (UNII: K49155WL9Y) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) KHAYA SENEGALENSIS BARK (UNII: 1S7EDA839L) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70186-700-01 1 in 1 CARTON 05/19/2022 1 30 mL in 1 TUBE; 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 05/19/2022 Labeler - Charlotte Tilbury Beauty Ltd. (218353520)
