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

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

Drug Labeling and Warnings

SOTHYS PARIS Sunscreen Face and Body Broad Spectrum SPF 30 UVA/UVB by is a Otc medication manufactured, distributed, or labeled by Sothys Paris. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51683-000
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 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51683-000-00	1 in 1 BOX	02/09/2014
1		125 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/09/2014

Labeler - Sothys Paris (271112281)