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

4-IN-1 Broad Spectrum SPF 50 Sunscreen by

Drug Labeling and Warnings

4-IN-1 Broad Spectrum SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Bio Jouvance, Cosmetic Science Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

INDICATIONS & USAGE

Stop use and ask a Physician if rash occurs.

WARNINGS

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.

DOSAGE & ADMINISTRATION

• apply liberally 15 minutes before sun exposure
• re-apply:
• after 40 minutes of swimming or sweating
• immediately after towel drying
• at least every two hours
• Sun Protection Meaures. Spending time under the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regurlarly use a sunscreen with an SPF of 15 or higher, and other sun protection meaures, including:
• limit time under 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.

INACTIVE INGREDIENT

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

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-272-1716

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80030-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80030-001-01	60 mL in 1 TUBE; Type 0: Not a Combination Product	08/19/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	08/19/2020

Labeler - Bio Jouvance (013516194)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetic Science Laboratories, LLC		018454384	manufacture(80030-001)