SOTHYS PARIS SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF 30 UVA/UVB- avobenzone, homosalate, octisalate, octocrylene cream 
Sothys Paris

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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SOTHYS PARIS Sunscreen Lotion Face and Body Broad Spectrum SPF 30 UVA/UVB

SOTHYS PARIS Sunscreen Lotion Face and Body Broad Spectrum SPF 30 UVA/UVB


Active ingredients

Avobenzone 3%
Homosalate 10%
Octisalate 5%
Octocrylene 8%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Do not use

  • on damaged or broken skin
  • in the eye contour

When using this product

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

  • rash occurs

Keep out of reach of children.

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

Directions

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10 a.m. - 2 p.m.
    • Wear long sleeved shirts, pants, hats and sunglasses
  • Children under 6 months of age: Ask a doctor

Other information

Protect the product in this container from excessive heat and direct sun

Inactive ingredients

Water, C12-15 Alkyl Benzoate, Polyurethan-34, Cetearyl Alcohol, Cyclohexasiloxane, Cyclopentasiloxane, Disodium EDTA, Ethylhexyl Salicylate, Ethylhexylglycerin, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Neopentyl Glycol Diheptanoate, Fragrance, Pentylene Glycol, Phenoxyethanol, Polyglyceryl-3 Methylglucose Distearate, Polysorbate 60, Sorbitan Isostearate, Tamarind (Tamarindus Indica) Seed Extract, Tocopheryl Acetate, Xanthan Gum.

SOTHYS PARIS Sunscreen Lotion Face and Body Broad Spectrum SPF 30 UVA/UVB 125ml (51683-000-00)

Outer Label

Inner Label

Leaflet

SOTHYS PARIS SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF 30 UVA/UVB 
avobenzone, homosalate, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51683-000
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) OCTOCRYLENE80 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
TAMARIND SEED (UNII: 6AHP8A7OML)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51683-000-001 in 1 BOX02/09/201412/31/2022
1125 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 finalpart35202/09/201412/31/2022
Labeler - Sothys Paris (271112281)

Revised: 1/2023
Document Id: f31e1c91-8ae4-7336-e053-2a95a90af91f
Set id: c14270e0-84f9-4cb2-9d46-c5879dd91863
Version: 10
Effective Time: 20230125
 
Sothys Paris