Drug Facts

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LA ROCHE-POSAY LABORATOIRE PHARMACEUTIQUE ROSALIAC UV FORTIFYING ANTI REDNESS MOISTURIZER SPF 15- avobenzone, octisalate and octocrylene 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 1.98%

Octislate 3.3%

Octocrylene 4.62

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • protects from UVA/UVB rays

Directions

  • apply evenly before sun exposure and as needed
  • 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 chlidren.

If swallowed, get medical help or contact a Poison Control Center right away.

Inactive ingredients

water, isononyl isononanoate, glycerin, niacinamide, diisopropyl sebacate, dimethicone, sucrose tristearate, cyclohexasiloxane, ammonium polyacryloyldimethyl taurate, methylsilsanol/silicate crosspolyhmer, ascorbyl glucoside, polysorbate 61, PEG-12 dimethicone, dimethiconol, caffeine, sodium citrate, sodium hydroxide, sodium stearoyl glutamate, disodium EDTA, citric acid, xanthan gum, sodium benzoate, phenoxyethanol, caprylyl clycol, blue 1, yellow 5

image of a label

LA ROCHE-POSAY LABORATOIRE PHARMACEUTIQUE ROSALIAC UV FORTIFYING ANTI REDNESS MOISTURIZER SPF 15 
avobenzone, octisalate and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66382-542
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone19.8 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate33 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene46.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
GLYCERIN (UNII: PDC6A3C0OX)  
NIACINAMIDE (UNII: 25X51I8RD4)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
SUCROSE TRISTEARATE (UNII: 71I93STU5M)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)  
POLYSORBATE 61 (UNII: X9E1MY2JQG)  
PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
DIMETHICONOL (70 CST) (UNII: MOT8IL21AR)  
CAFFEINE (UNII: 3G6A5W338E)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66382-542-011 in 1 CARTON12/01/200906/01/2015
140 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35212/01/200906/01/2015
Labeler - Laboratoires Industriels de Vichy (LIDV) (282658798)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoires Industriels de Vichy (LIDV)282658798manufacture(66382-542)

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