Drug Facts

Drug Labeling and Warnings

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LA ROCHE-POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 45 ULTRA LIGHT SUNSCREEN FLUID SPF 45- avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion 
Laboratoires Industriels de Vichy (LIDV)

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 10%

Octisalate 5%

Octocrylene 5%

Oxybenzone 6%

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • retains SPF after 40 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 

Directions

  • shake well before use
  • apply evenly before sun exposure
  • reapply as needed or after towel drying, swimming, or perspiring
  • children under 6 months of age: ask a doctor

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, dicaprylyl ether, styrene/acrulates copolymer, PEG-30 dipolyhydroxystearate, dimethicone, cyclohexasiloxane, polymethylsilsesquioxane, nylon-12, dicarylyl carbonate, phenoxyethanol, lauryl PEG/PPG-18/18 methicone, sodium chloride, caprylyl glycol, methylparaben, poly C10-30 alkyl acrylate, disteardimonium hectorite, disodium EDTA, diethylhexyl syringylidenemalonate, cassia alata leaf extract, maltodextrin, dodenene, poloxamer 407

image of a label

LA ROCHE-POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 45 ULTRA LIGHT SUNSCREEN FLUID SPF 45 
avobenzone, homosalate, octisalate, octocrylene and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66382-222
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) Homosalate100 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)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
SENNA ALATA LEAF (UNII: 4BXR6YZN92)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
DODECENE (UNII: WYE669F3GR)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66382-222-011 in 1 CARTON04/01/201006/01/2015
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/201006/01/2015
Labeler - Laboratoires Industriels de Vichy (LIDV) (282658798)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Industriels de Vichy (LIDV)282658798manufacture(66382-222)

Revised: 8/2019
 
Laboratoires Industriels de Vichy (LIDV)