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

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.

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Stila Hydrating Primer Oil-Free SPF 30
(All Shades)

Drug Facts

Active Ingredients Purpose
  Avobenzone3.00% sunscreen
  Octisalate5.00% sunscreen
  Octinoxate7.50% 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>.

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

Principal Display Panel - 50 ml Tube Carton
STILA HYDRATING PRIMER OIL-FREE SPF 30   (ALL SHADES)
avobenzone, octisalate, and octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76049-715
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate5 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76049-715-011 in 1 CARTON
150 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/30/2013
Labeler - Stila Styles, LLC (809192896)
Establishment
NameAddressID/FEIBusiness Operations
MANA PRODUCTS078870292MANUFACTURE(76049-715)

Revised: 11/2013
Document Id: 388fe1a5-c183-4bdd-a6ac-e491714c5161
Set id: 0773df86-b8a3-48b1-9720-b47ddcf62f17
Version: 1
Effective Time: 20131118
 
Stila Styles, LLC