STILA HYDRATING PRIMER OIL-FREE SPF 30 (ALL SHADES)- avobenzone, octisalate, and octinoxate lotion

Stila Hydrating Primer Oil-Free SPF 30 by

Drug Labeling and Warnings

Stila Hydrating Primer Oil-Free SPF 30 by is a Otc medication manufactured, distributed, or labeled by Stila Styles, LLC, MANA PRODUCTS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active Ingredients			Purpose
Avobenzone	3.00%		sunscreen
Octisalate	5.00%		sunscreen
Octinoxate	7.50%		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 see 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), octyldodecyl neopentanoate, c12-15 alkyl benzoate, propylene glycol, cetearyl alcohol, butyrospermum parkii (shea) butter, butylene glycol, coco-glucoside, persea gratissima(avocado) oil, squalane, corylus avellana (hazel) seed oil, simmondsia chinensis (jojoba) seed oil, tocopheyl acetate, ascorbyl palmitate, glyceryl stearate, behenyl alcohol, palmitic acid, stearic acid, lecithin, lauryl alcohol, myristyl alcohol, cetyl alcohol, bisabolol, centella asiatica extract, echinacea purpurea extract, algae extract, panax ginseng (ginseng) root extract, sodium hyaluronate, pentylene glycol, glycerin, sodium lactate, lactic acid, serine, urea, sorbitol, sodium chloride, allantoin, cucumis sativus (cucumber) oil, carbomer, microcrystalline cellulose, dimethicone, sodium hydroxide, disodium edta, phenoxyethanol, o-cymen-5-ol, ethylhexylglycerin, may contain (+/-): red 4 (ci 14700) <iln c111008>.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

stila

hydrating primer
oil-free
SPF 30

1.7 fl. oz./50 ml

INGREDIENTS AND APPEARANCE

STILA HYDRATING PRIMER OIL-FREE SPF 30   (ALL SHADES)
avobenzone, octisalate, and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76049-715
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	3 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	5 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	7.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
octyldodecyl neopentanoate (UNII: X8725R883T)
alkyl (c12-15) benzoate (UNII: A9EJ3J61HQ)
propylene glycol (UNII: 6DC9Q167V3)
cetostearyl alcohol (UNII: 2DMT128M1S)
shea butter (UNII: K49155WL9Y)
butylene glycol (UNII: 3XUS85K0RA)
coco glucoside (UNII: ICS790225B)
avocado oil (UNII: 6VNO72PFC1)
squalane (UNII: GW89575KF9)
european hazelnut oil (UNII: 8RQ2839AVG)
jojoba oil (UNII: 724GKU717M)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)
ascorbyl palmitate (UNII: QN83US2B0N)
glyceryl monostearate (UNII: 230OU9XXE4)
docosanol (UNII: 9G1OE216XY)
palmitic acid (UNII: 2V16EO95H1)
stearic acid (UNII: 4ELV7Z65AP)
lauryl alcohol (UNII: 178A96NLP2)
myristyl alcohol (UNII: V42034O9PU)
cetyl alcohol (UNII: 936JST6JCN)
levomenol (UNII: 24WE03BX2T)
centella asiatica (UNII: 7M867G6T1U)
echinacea purpurea (UNII: QI7G114Y98)
asian ginseng (UNII: CUQ3A77YXI)
hyaluronate sodium (UNII: YSE9PPT4TH)
pentylene glycol (UNII: 50C1307PZG)
glycerin (UNII: PDC6A3C0OX)
sodium lactate (UNII: TU7HW0W0QT)
lactic acid (UNII: 33X04XA5AT)
serine (UNII: 452VLY9402)
urea (UNII: 8W8T17847W)
sorbitol (UNII: 506T60A25R)
sodium chloride (UNII: 451W47IQ8X)
allantoin (UNII: 344S277G0Z)
cucumber seed oil (UNII: AKP926H71P)
cellulose, microcrystalline (UNII: OP1R32D61U)
dimethicone (UNII: 92RU3N3Y1O)
sodium hydroxide (UNII: 55X04QC32I)
edetate disodium (UNII: 7FLD91C86K)
phenoxyethanol (UNII: HIE492ZZ3T)
o-cymen-5-ol (UNII: H41B6Q1I9L)
ethylhexylglycerin (UNII: 147D247K3P)
fd&c red no. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76049-715-01	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	part352	08/30/2013

Labeler - Stila Styles, LLC (809192896)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS		078870292	MANUFACTURE(76049-715)