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
- DEA Schedule: None
- Marketing Status: OTC monograph 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 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)