SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF 30- octocrylene, octinoxate, oxybenzone, avobenzone 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.

----------

Sunscreen Lotion Face and Body Broad Spectrum SPF 30

Drug Facts

Active ingredients

Octocrylene 10%
Octyl methoxycinnamate 7.5%
Oxybenzone 5%
Avobenzone 3%

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

Acrylamide/sodium acryloyldimethyltaurate copolymer, Ammonium acryloyldimethyltaurate/ VP copolymer, Aqua (Water), Butylene glycol, C12-15 alkyl benzoate, Caprylhydroxamic acid, Caprylyl glycol, Dicaprylyl carbonate, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate, Helianthus annuus (Sunflower) seed extract, Isohexadecane, Parfum (Fragrance), PEG-100 stearate, Phenoxyethanol, Polymethyl methacrylate, Polysorbate 80, Potassium Cetyl phosphate, Sorbitan oleate, Sorbitan stearate, Tocopherol, Tocopheryl acetate, VP/eicosene
copolymer

Package Labeling:

LabelLotion

SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF 30 
octocrylene, octinoxate, oxybenzone, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51683-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SUNFLOWER SEED (UNII: R9N3379M4Z)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51683-002-011 in 1 BOX06/08/201610/21/2022
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 finalpart35206/08/201610/21/2022
Labeler - Sothys Paris (271112281)
Establishment
NameAddressID/FEIBusiness Operations
Cofran International Corp122716855pack(51683-002)

Revised: 1/2023
Document Id: eec659bb-c087-7d2f-e053-2995a90a1da8
Set id: 3517751e-e5f0-4001-bc83-712b6a0781ee
Version: 4
Effective Time: 20230119
 
Sothys Paris