STILA BRONZING TINTED MOISTURIZER OIL-FREE SPF 20- titanium dioxide and zinc oxide lotion

stila bronzing tinted moisturizer oil-free SPF 20 by

Drug Labeling and Warnings

stila bronzing tinted moisturizer oil-free SPF 20 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

Provides moderate protection against sunburn.

Sun Alert

The sun may cause sunburn, premature aging of the skin, and skin cancer. Avoiding the sun, wearing protective clothing, and regular use of sunscreens over the years may reduce the chance of harmful effects.

Warnings

For external use only.

When using this product

Keep out of eyes.

Stop use and ask a doctor if

Irritation occurs.

Keep out of reach of children.

Do not use on infants under 6 months old.

Directions

Blend over entire face with fingertips.

Inactive Ingredients

water (aqua), cyclopentasiloxane, propylene, glycol, octyldodecyl neopentanoate, peg/ppg-18/18 dimethicone, dimethicone, cyclohexasiloxane, phytantriol, magnesium ascorbyl phosphate, retinyl palmitate, tocopheryl acetate, tocopherol, tetrahexyldecyl ascorbate, aluminum hydroxide, stearic acid, triethoxycaprylylsilane, boron nitride, glycerin, sodium dehydroacetate, palmitic acid, dextrin palmitate, sodium hyaluronate, butylene glycol, panax ginseng (ginseng) root extract, ginkgo biloba leaf extract, anthemis nobilis (chamomile) flower extract, camellia oleifera (camelia oleifera) leaf extract, magnesium chloride, potassium chloride, sodium chloride, zinc chloride, lysine, phenoxyethanol, hexylene glycol, caprylyl glycol, may contain (+/-): mica, titanium dioxide (ci 77891), iron oxides (ci 77491, ci 77492, ci 77499 <iln c101014r2>.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 ml Tube Label

stila

bronzing
tinted moisturizer

oil-free

SPF 20

1.7 fl. oz./oz. liq./50 ml e

INGREDIENTS AND APPEARANCE

STILA BRONZING TINTED MOISTURIZER OIL-FREE SPF 20 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76049-554
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
water (UNII: 059QF0KO0R)
cyclomethicone 5 (UNII: 0THT5PCI0R)
propylene glycol (UNII: 6DC9Q167V3)
octyldodecyl neopentanoate (UNII: X8725R883T)
peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794)
dimethicone (UNII: 92RU3N3Y1O)
cyclomethicone 6 (UNII: XHK3U310BA)
phytantriol (UNII: 8LVI07A72W)
magnesium ascorbyl phosphate (UNII: 0R822556M5)
vitamin a palmitate (UNII: 1D1K0N0VVC)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
tocopherol (UNII: R0ZB2556P8)
tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ)
aluminum hydroxide (UNII: 5QB0T2IUN0)
stearic acid (UNII: 4ELV7Z65AP)
triethoxycaprylylsilane (UNII: LDC331P08E)
boron nitride (UNII: 2U4T60A6YD)
glycerin (UNII: PDC6A3C0OX)
sodium dehydroacetate (UNII: 8W46YN971G)
palmitic acid (UNII: 2V16EO95H1)
hyaluronate sodium (UNII: YSE9PPT4TH)
butylene glycol (UNII: 3XUS85K0RA)
asian ginseng (UNII: CUQ3A77YXI)
ginkgo (UNII: 19FUJ2C58T)
chamaemelum nobile flower (UNII: O2T154T6OG)
camellia oleifera leaf (UNII: 5077EL0C60)
magnesium chloride (UNII: 02F3473H9O)
potassium chloride (UNII: 660YQ98I10)
sodium chloride (UNII: 451W47IQ8X)
zinc chloride (UNII: 86Q357L16B)
lysine (UNII: K3Z4F929H6)
phenoxyethanol (UNII: HIE492ZZ3T)
hexylene glycol (UNII: KEH0A3F75J)
caprylyl glycol (UNII: 00YIU5438U)
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: 76049-554-01	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(76049-554)