LOreal Paris Sublime Sun Advanced Sunscreen SPF 50 Plus

Dosage form: lotion
Ingredients: Avobenzone 2.64mL in 88mL, Homosalate 13.2mL in 88mL, Octisalate 4.4mL in 88mL, Octocrylene 4.4mL in 88mL, Oxybenzone 5.28mL in 88mL
Labeler: L'Oreal USA Products Inc
NDC Code: 49967-369

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 15%

Octisalate 5%

Octocrylene 5%

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

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
  • reapply after swimming, towel drying, and excessive sweating
  • children under 6 months of age: ask a doctor

Inactive ingredients

water, silica, styrene/acrylates copolymer, butyloctyl salicylate, cyclopentasiloxane, glycerin, poly c10-30 alkyl acrylate, PEG-100 stearate, glyceryl stearate, caprylyl methicone, trisiloxane, PEG-8 laurate, dicaprylyl carbonate, potassium cetyl phosphate, dimethicone, triethanolamine, dimethicone crosspolymer, methylparaben, vitis vinifera (grape) fruit extract, inulin lauryl carbamate, phenoxyethanol, chlorphenesin, disodium EDTA, tocopherol, caprylyl glocol, xanthan gum, acrylates/dimethicone copolymer, acrylates/c10-30 alkyl acrylate crosspolymer, ethylparaben

LOREAL PARIS SUBLIME SUN  ADVANCED SUNSCREEN SPF 50 PLUS
avobenzone homosalate octisalate octocrylene oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-369
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone2.64 mL  in 88 mL
Homosalate (Homosalate) Homosalate13.2 mL  in 88 mL
Octisalate (Octisalate) Octisalate4.4 mL  in 88 mL
Octocrylene (Octocrylene) Octocrylene4.4 mL  in 88 mL
Oxybenzone (Oxybenzone) Oxybenzone5.28 mL  in 88 mL
Packaging
#Item CodePackage Description
1NDC:49967-369-0188 mL in 1 TUBE
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
L'Oreal USA Products Inc624244349manufacture

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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