STILA STAY ALL DAY 10-IN-1 HD ILLUMINATING BEAUTY BALM BROAD SPECTRUM SPF 30- octinoxate and zinc oxide cream

Stila Stay All Day 10-in-1 HD Illuminating Beauty Balm Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Stila Stay All Day 10-in-1 HD Illuminating Beauty Balm Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Stila Styles, LLC, GORDON LABORATORIES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients			Purpose
Octinoxate	5.00%		sunscreen
Zinc Oxide	18.60%		sunscreen

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

For external use only

Do not use on damaged or broken skin

Stop use and ask a doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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
• 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

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

Protect this product from excessive heat and direct sun

Questions?

stilacosmetics.com

SPL UNCLASSIFIED SECTION

dist. by stila styles, llc los angeles, ca 90027

PRINCIPAL DISPLAY PANEL - 40 ml Tube Carton

stila

stay all day™ 10-in-1
HD illuminating beauty balm

broad spectrum SPF 30

water-resistant (80 minutes)
1.3 fl. oz./40 ml

INGREDIENTS AND APPEARANCE

STILA STAY ALL DAY 10-IN-1 HD ILLUMINATING BEAUTY BALM BROAD SPECTRUM SPF 30 
octinoxate and zinc oxide cream

Product 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)