4-IN-1 BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate, oxybenzone cream 
Cosmetic Science Laboratories LLC

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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4-IN-1 Broad Spectrum SPF 50 Sunscreen

Purpose Sunscreen

Avobenzone 3.0%, Homosalate 15%, Octocrylene 8.0%, Octisalate 5.0%, Oxybenzone 5.0%

Sunscreen

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.

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

Stop use and ask a Physician if rash occurs.

For external use only.

Do not use on damaged or broken skin

When using this product, keep out of eyes. Rinse with water to remove.

  • apply liberally 15 minutes beofre sun exposure
  • re-apply: after 40 minutes of swiming or sweating
  • immediately after towel drying
  • at least every two hours
  • Sun Protection Measures. Spending time under the sun increases your risk of skin cancer and early skin aging. To decrease the riksk, regularly use a sunscreen with an SPF of 15 or higher, and other sun proctection meausres, including:
  • limit time uder the sun, especially from 10:00 a.m. to 2:00 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a Physician if exposure would be advised.

water, stearic acid, glyceryl stearate, PEG-100 stearate, elaeis guineensis (palm) kenel oil, aloe barbadensis leaf extract, retinyl palmitate, pyridoxine hydrochloride, cyanocobalamin, ascorbic acid, tocopheryl acetate, sodium hyaluronate crosspolymer, dimethicone, polysorbate 60, carbomer, triethanolamine, DMDM hydantoin, diazolidinyl urea, iodopropynyl butylcarbamate

protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-272-1716

BIO JOUVANCE

4-IN-1 BROAD SPECTRUM

SPF 50 SUNSCREEN

FACE/BODY

2 fl. oz. 60 ml

4-IN-1 SPF 50

4-IN-1 BROAD SPECTRUM SPF 50 SUNSCREEN 
avobenzone, homosalate, octocrylene, octisalate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73561-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PALM KERNEL OIL (UNII: B0S90M0233)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
CYANOCOBALAMIN (UNII: P6YC3EG204)  
PEG-100 STEARATE (UNII: YD01N1999R)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73561-001-0160 mL in 1 TUBE; Type 0: Not a Combination Product08/19/202010/25/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/19/202010/25/2021
Labeler - Cosmetic Science Laboratories LLC (018454384)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Science Laboratories LLC018454384manufacture(73561-001)

Revised: 3/2023
 
Cosmetic Science Laboratories LLC