Label: STUDIO FIX FLUID SPF 15 BROAD SPECTRUM- octinoxate and titanium dioxide liquid
- NDC Code(s): 40046-0072-1
- Packager: MAKEUP ART COSMETICS
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated August 31, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
- Warnings
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Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply every two hours
- use a water resistant sunscreen if swimming or sweating
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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 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
- children under 6 months of age: ask a doctor
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inactive ingredients
water/aqua/eau, cyclopentasiloxane, peg-10 dimethicone, butylene glycol, trimethylsiloxysilicate, dimethicone, magnesium sulfate, laminaria saccharina extract, algae extract, tocopheryl acetate, sodium hyaluronate, tocopherol, lecithin, hydrogenated lecithin, xanthan gum, sorbitan sesquioleate, methoxy amodimethicone/silsesquioxane copolymer, laureth-7, dipropylene glycol, dimethicone/peg-10/15 crosspolymer, dimethicone/peg-10 crosspolymer, peg/ppg-18/18 dimethicone, disteardimonium hectorite, silica, dimethicone crosspolymer, triethoxycaprylylsilane, propylene carbonate, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, sorbic acid, chloroxylenol, phenoxyethanol [+/- titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499), chromium oxide greens (ci 77288)] <iln36878>
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 ML Bottle Carton
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INGREDIENTS AND APPEARANCE
STUDIO FIX FLUID SPF 15 BROAD SPECTRUM
octinoxate and titanium dioxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:40046-0072 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 25 mg in 1 mL TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) DIMETHICONE (UNII: 92RU3N3Y1O) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) SACCHARINA LATISSIMA (UNII: 68CMP2MB55) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TOCOPHEROL (UNII: R0ZB2556P8) XANTHAN GUM (UNII: TTV12P4NEE) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) LAURETH-7 (UNII: Z95S6G8201) DIPROPYLENE GLYCOL (UNII: E107L85C40) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) PROPYLENE CARBONATE (UNII: 8D08K3S51E) PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) SORBIC ACID (UNII: X045WJ989B) CHLOROXYLENOL (UNII: 0F32U78V2Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) CHROMIC OXIDE (UNII: X5Z09SU859) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:40046-0072-1 1 in 1 CARTON 12/01/2005 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 final M020 12/01/2005 Labeler - MAKEUP ART COSMETICS (010597206) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 202952982 manufacture(40046-0072) Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Ltd. 204132062 pack(40046-0072) , label(40046-0072)
