Label: STILA STAY ALL DAY 10-IN-1 HD ILLUMINATING BEAUTY BALM BROAD SPECTRUM SPF 30- octinoxate and zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76049-879-01 - Packager: Stila Styles, LLC
- 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 November 25, 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
butylphenyl methyl propional, c12-15 alkyl benzoate, caprylic/capric triglyceride, caprylyl glycol, cyclopentasiloxane, decarboxy carnosine hcl, dimethicone, dimethicone crosspolymer , ethylhexylglycerin, fragrance/parfum, glycerin, helianthus annuus (sunflower) seed oil, hexyl cinnamic aldehyde, hexylene glycol, hydroxypropylcocoate peg-8 dimethicone, isododecane , isopentyldiol, limonene, linalool, palmitoyl tripeptide-37, peg/ppg-18/18 dimethicone, phenoxyethanol, physalis angulata extract , phytic acid, polyhydroxystearic acid, propylene carbonate, pyrus malus (apple) fruit extract, rosmarinus officinalis (rosemary) leaf extract, silica, sodium chloride, sodium hydroxide, tocopherol, triethoxycaprylylsilane, water (aqua) , may contain (+\-): mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499) <iln c121042>.
- Other Information
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton
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INGREDIENTS AND APPEARANCE
STILA STAY ALL DAY 10-IN-1 HD ILLUMINATING BEAUTY BALM BROAD SPECTRUM SPF 30
octinoxate and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76049-879 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 50 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 186 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DECARBOXY CARNOSINE HYDROCHLORIDE (UNII: 6X7K9I5QR7) DIMETHICONE (UNII: 92RU3N3Y1O) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) SUNFLOWER OIL (UNII: 3W1JG795YI) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) HEXYLENE GLYCOL (UNII: KEH0A3F75J) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) ISODODECANE (UNII: A8289P68Y2) ISOPENTYLDIOL (UNII: 19NOL5474Q) LINALOOL, (+/-)- (UNII: D81QY6I88E) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) PHENOXYETHANOL (UNII: HIE492ZZ3T) PHYSALIS ANGULATA (UNII: W4TKW9D5GG) FYTIC ACID (UNII: 7IGF0S7R8I) PROPYLENE CARBONATE (UNII: 8D08K3S51E) APPLE (UNII: B423VGH5S9) ROSEMARY (UNII: IJ67X351P9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM HYDROXIDE (UNII: 55X04QC32I) TOCOPHEROL (UNII: R0ZB2556P8) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 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:76049-879-01 1 in 1 CARTON 1 40 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 08/31/2013 Labeler - Stila Styles, LLC (809192896) Establishment Name Address ID/FEI Business Operations GORDON LABORATORIES, INC. 008328619 MANUFACTURE(76049-879)
