Drug Facts

Drug Labeling and Warnings

Drug Details [pdf]

LA ROCHE POSAY ANTHELIOS 30 ULTRALIGHT SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene and oxybenzone 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 12%

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 or perspiring
  • provides protection from the UVA rays that may contribute to skin damage and premature aging of the skin

Warnings

For external use only

When using this product

  • keep out of eyes. Rinse with water to remove.
  • keep away from face to avoid breathing it

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



  • hold can 4 - 6 inches away from body and apply liberally and evenly before sun exposure
  • for face, do not spray directly on face; spray into hands and apply using fingers
  • reapply as needed or after towel drying,swimming, or perspiring
  • children under 6 months of age: ask a doctor
  • do not apply in windy conditions
  • use in a well-ventilated area

Inactive ingredients

dimethicone, water, isododecane, isononyl isononanoate, PEG-10 dimethicone, styrene/acrylates copolymer, PEG-30 dipolyhydroxystearate, dicaprylyl carbonate, trisiloxane, dimethicone/PEG-10/15 crosspolyer, sodium chloride, phenoxyethanol, propylene glycol, PEG-8 laurate, disteardimonium hectorite, tocopherol, disodium EDTA, p-anisic acid, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin, propylene carbonate

image of a label

LA ROCHE POSAY ANTHELIOS 30 ULTRALIGHT SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49967-085
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate120 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene70 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone60 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE (UNII: 92RU3N3Y1O)  
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
TRISILOXANE (UNII: 9G1ZW13R0G)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
TOCOPHEROL (UNII: R0ZB2556P8)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49967-085-01143 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/01/201207/12/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/201207/12/2018
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
NameAddressID/FEIBusiness Operations
Assured Packaging248916165manufacture(49967-085)

Revised: 12/2018