4-IN-1 BROAD SPECTRUM SPF 50 SUNSCREEN- avobenzone, homosalate, octocrylene, octisalate, oxybenzone cream 
Bio Jouvance

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%

Uses

helps prevent sunburn

if used as directed with other sun protection measures (see directions), decrease 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 used on damaged or broken skin. When using this product, keep out of eyes. Rinse with water to remove.

water, stearic acid, glyceryl stearate, PEG-100 stearate, elaeis guineensis kernel oil, aloe barbadensis leaft ectract, 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

PARIS

4-in-1 BROAD SPECTRUM SPF 50 SUNSCREEN

FACE/BODY

2 FL. OZ. 60 ml

DISTRIBUTED BY BIOJOUVANCE INC.

LOS ANGELES, CA 90039

WWW.BIOJOUVANCE.COM

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:80030-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PEG-100 STEARATE (UNII: YD01N1999R)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PALM KERNEL OIL (UNII: B0S90M0233)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
CYANOCOBALAMIN (UNII: P6YC3EG204)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80030-001-0160 mL in 1 TUBE; Type 0: Not a Combination Product08/19/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/19/2020
Labeler - Bio Jouvance (013516194)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Science Laboratories, LLC018454384manufacture(80030-001)

Revised: 8/2020
Document Id: ad3ff9fa-1dea-19ed-e053-2995a90a684e
Set id: ad3ff9fa-1de9-19ed-e053-2995a90a684e
Version: 1
Effective Time: 20200819
 
Bio Jouvance