Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

LOREAL PARIS SUBLIME SUN ADVANCED SUNSCREEN SPF 50 PLUS CRYSTAL CLEAR MIST- avobenzone, homosalate, octisalate, octocrylene and oxybenzone aerosol, spray 
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 ingredients

Avobenzone 3%; Homosalate 15%; Octisalate 5%; Octocrylene 7%; Oxybenzone 6%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water

Warnings

For external use

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

rash or irritation develops and lasts

FLAMMABLE

  • do not use when smoking or near flame. use only in a ventilated area
  • avoid spraying in eyes
  • contents under pressure. do not puncture or incinerate
  • do not store at temperatures above 120F
  • keep out of reach of children
  • use only as directed. intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal

Keep out of reach of children.

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

Directions

  • apply generously 15-30 minutes before sun exposure
  • hold can 4-6 inches away from body and apply liberally, spraying slowly and evenly until product is visible on skin
  • reapply after swimming, towel drying, and excessive sweating
  • do not apply in windy conditions
  • children under 6 months of age: ask a doctor
  • do not spray into face, spray on hands and apply to the face

Inactive ingredients

alcohol denat., c12-15 alkyl benzoate, dicaprytyl carbonate, vitis vinifera (grape) seed oil, tocopherol, acrylates/octylacrylamide copolymer

image of a label

LOREAL PARIS SUBLIME SUN ADVANCED SUNSCREEN SPF 50 PLUS CRYSTAL CLEAR MIST 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49967-359
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate150 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene70 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49967-359-01125 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/201101/19/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/201101/19/2018
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Assured Packaging Inc.248916165manufacture(49967-359)

Revised: 12/2018
Document Id: b6b5bac4-601d-4e37-ae3c-4d4107c5675a
Set id: 862928a9-e2bd-4943-a242-9d7ee37af3e8
Version: 4
Effective Time: 20181228
 
L'Oreal USA Products Inc