LOreal Paris Sublime Sun Advanced Sunscreen SPF 30 Crystal Clear Mist

Dosage form: aerosol, spray
Ingredients: Avobenzone 3.75mL in 125mL, Homosalate 12.5mL in 125mL, Octisalate 6.25mL in 125mL, Octocrylene 8.75mL in 125mL
Labeler: L'Oreal USA Products Inc
NDC Code: 49967-358

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.

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 7%


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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

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

LOREAL PARIS SUBLIME SUN  ADVANCED SUNSCREEN SPF 30 CRYSTAL CLEAR MIST
avobenzone homosalate octisalate octocrylene aerosol, spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-358
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone3.75 mL  in 125 mL
Homosalate (Homosalate) Homosalate12.5 mL  in 125 mL
Octisalate (Octisalate) Octisalate6.25 mL  in 125 mL
Octocrylene (Octocrylene) Octocrylene8.75 mL  in 125 mL
Packaging
#Item CodePackage Description
1NDC:49967-358-01125 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2011
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIOperations
Assured Packaging Inc.248916165manufacture

Revised: 10/2011
 
L'Oreal USA Products Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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