STILA SHEER COLOR TINTED MOISTURIZER BS SPF20 (ALL SHADES)- titanium dioxide and zinc oxide lotion

Stila Sheer color tinted moisturizer BS SPF20 by

Drug Labeling and Warnings

Stila Sheer color tinted moisturizer BS SPF20 by is a Otc medication manufactured, distributed, or labeled by Stila Styles, LLC, MANA PRODUCTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
Titanium Dioxide 5.00%	sunscreen
Zinc Oxide 5.00%	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

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

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 - 50 ml Tube Carton

stila

sheer color
tinted moisturizer
broad spectrum SPF 20

oil-free
water-resistant (80 minutes)

1.7 fl. oz./50 ml

INGREDIENTS AND APPEARANCE

STILA SHEER COLOR TINTED MOISTURIZER BS SPF20   (ALL SHADES)
titanium dioxide and zinc oxide lotion

Product 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)