Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS SUPER FLUID UV DEFENSE ULTRA LIGHT SUNSCREEN SPF 50 PLUS- avobenzone, homosalate, octisalate, octocrylene and oxybenzone 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 ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 5%

Oxybenzone 6%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • provides protection from the UVA rays that may contribute to skin damage and premature aging of the skin

Directions

  • apply liberally before sun exposure and as needed
  • children under 6 months of age: ask a doctor
  • shake well before using/applying

Warnings

For external use only

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.

Inactive ingredients

water, cyclopentasiloxane, alcohol denat., silica, dicaprytyl ether, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsequioxane, nylon-12, dicapryly caronate, phenoxyethanol, lauryl PEG/PPG-18/8 methicone, sodium chloride, caprylyl glycol, methylparaben, poly c10-30 alkyl acrylate, diistearmonium hectorite, disodium EDTA, dodecene, poloxamer 407

image of a label

KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS SUPER FLUID UV DEFENSE ULTRA LIGHT SUNSCREEN SPF 50 PLUS 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49967-444
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) Octocrylene50 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
ALCOHOL (UNII: 3K9958V90M)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
NYLON-12 (UNII: 446U8J075B)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
DODECENE (UNII: WYE669F3GR)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49967-444-011 in 1 CARTON06/01/201012/31/2018
150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/201012/31/2018
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
L'Oreal USA Products Inc185931458manufacture(49967-444)

Revised: 8/2019