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 Type HUMAN OTC DRUG Item Code (Source) NDC:49967-085
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 30 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate 120 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 70 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 60 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:49967-085-01 143 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/01/2012 07/12/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 01/01/2012 07/12/2018
Labeler - L'Oreal USA Products Inc (002136794)
Establishment
Name Address ID/FEI Business Operations
Assured Packaging 248916165 manufacture(49967-085)

Revised: 12/2018
L'Oreal USA Products Inc