Label: STILA SHEER COLOR TINTED MOISTURIZER BS SPF20 (ALL SHADES)- titanium dioxide and zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 76049-556-01 - Packager: Stila Styles, LLC
- 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 November 22, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
"Helps prevent sunburn"
"If used as directed with other protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure
- Reapply:
- After 80 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- Children under 6 months: Ask a doctor
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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 am – 2 pm
- Wear long-sleeved shirts, pants, hats and sunglasses
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Inactive Ingredients
aluminum hydroxide, anthemis nobilis (chamomile) flower extract, boron nitride, butylene glycol, camellia oleifera (camilia oleifera) leaf extract, caprylyl glycol, cyclohexasiloxane, cyclopentasiloxane, dextrin palmitate, dimethicone, ginkgo biloba leaf extract, glycerin, hexylene glycol, lysine, magnesium ascorbyl phosphate, magnesium chloride, octyldodecyl neopentanoate, palmitic acid, panax ginseng (ginseng) root extract, peg/ppg-18/18 dimethicone, phenoxyethanol, phytantriol, potassium chloride, propylene glycol, retinyl palmitate, sodium chloride, sodium dehydroacetate,sodium hyaluronate, stearic acid, tetrahexyldecyl ascorbate, tocopherol, tocopheryl acetate, triethoxycaprylylsilane, water (aqua), zinc chloride, may contain (+\-): mica, titanium dioxide (ci 77891), iron oxides (ci 77491, 77492, 77499) <iln c121004>.
- Other Information
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton
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INGREDIENTS AND APPEARANCE
STILA SHEER COLOR TINTED MOISTURIZER BS SPF20 (ALL SHADES)
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76049-556 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 50 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength aluminum hydroxide (UNII: 5QB0T2IUN0) chamaemelum nobile flower (UNII: O2T154T6OG) boron nitride (UNII: 2U4T60A6YD) butylene glycol (UNII: 3XUS85K0RA) camellia oleifera leaf (UNII: 5077EL0C60) caprylyl glycol (UNII: 00YIU5438U) cyclomethicone 6 (UNII: XHK3U310BA) cyclomethicone 5 (UNII: 0THT5PCI0R) dimethicone (UNII: 92RU3N3Y1O) ginkgo (UNII: 19FUJ2C58T) glycerin (UNII: PDC6A3C0OX) hexylene glycol (UNII: KEH0A3F75J) lysine (UNII: K3Z4F929H6) magnesium ascorbyl phosphate (UNII: 0R822556M5) magnesium chloride (UNII: 02F3473H9O) octyldodecyl neopentanoate (UNII: X8725R883T) palmitic acid (UNII: 2V16EO95H1) asian ginseng (UNII: CUQ3A77YXI) peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794) phenoxyethanol (UNII: HIE492ZZ3T) phytantriol (UNII: 8LVI07A72W) potassium chloride (UNII: 660YQ98I10) propylene glycol (UNII: 6DC9Q167V3) vitamin a palmitate (UNII: 1D1K0N0VVC) sodium chloride (UNII: 451W47IQ8X) sodium dehydroacetate (UNII: 8W46YN971G) hyaluronate sodium (UNII: YSE9PPT4TH) stearic acid (UNII: 4ELV7Z65AP) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) tocopherol (UNII: R0ZB2556P8) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) triethoxycaprylylsilane (UNII: LDC331P08E) water (UNII: 059QF0KO0R) zinc chloride (UNII: 86Q357L16B) mica (UNII: V8A1AW0880) ferric oxide red (UNII: 1K09F3G675) ferric oxide yellow (UNII: EX438O2MRT) ferrosoferric oxide (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76049-556-01 1 in 1 CARTON 1 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/31/2013 Labeler - Stila Styles, LLC (809192896) Establishment Name Address ID/FEI Business Operations MANA PRODUCTS 078870292 MANUFACTURE(76049-556)