YVES SAINT LAURENT ALL HOURS PRIMER BROAD SPECTRUM SPF 18 SUNSCREEN- octinoxate lotion 
L'Oreal USA Products Inc

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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Drug Facts

Active ingredient

Octinoxate 6.5%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Flammable until dry.

Avoid fire, flame and heat during application.

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 a.m. - 2 p.m.
  •                 wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: Ask a doctor

Other information

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, dimethicone, isododecane, alcohol, trimethylsiloxysilicate, butylene glycol, PEG-10 dimethicone, titanium dioxide, perlite, nylon-12, lauryl methacrylate/glycol dimethacrlyate crosspolymer, HDI/trimethylol hexyllactone crosspolymer, bismuth oxychloride, BIS-PEG/PPG-14/14 dimethicone, magnesium sulfate, silica silylate, phenoxyethanol, disteardimonium hectorite, aluminum hydroxide, dipentaerythrityl tetrahydroxystearate/tetraisostearate, hydrogen dimethicone, tocopherol, propylene glycol, silica, iron oxides, BHT, synthetic fluorphlogopite, rosa centifolia flower extract, disodium stearoyl glutamate

image of a carton

YVES SAINT LAURENT ALL HOURS PRIMER BROAD SPECTRUM SPF 18 SUNSCREEN 
octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-403
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
ISODODECANE (UNII: A8289P68Y2)  
ALCOHOL (UNII: 3K9958V90M)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PERLITE (UNII: 0SG101ZGK9)  
NYLON-12 (UNII: 446U8J075B)  
LAURYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EX0F4CZ66H)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
BIS-PEG/PPG-14/14 DIMETHICONE (UNII: X2I70H0QJE)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
DIPENTAERYTHRITYL TETRAHYDROXYSTEARATE/TETRAISOSTEARATE (UNII: 230K0823CE)  
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)  
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49967-403-011 in 1 CARTON06/01/201706/08/2020
140 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49967-403-021 mL in 1 PACKET; Type 0: Not a Combination Product06/01/201711/30/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201706/08/2020
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
SICOS ET CIE276993581manufacture(49967-403)
Establishment
NameAddressID/FEIBusiness Operations
BPS60272259304pack(49967-403)

Revised: 1/2023
 
L'Oreal USA Products Inc