SOLBAR FIFTY SPF50- solbar fifty spf50 cream 
Person and Covey

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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Solbar Fifty SPF50

WARNINGS AND PRECAUTIONS SECTION

For external use only. Do not use on damaged or broken skin. Keep out of eyes. Rinse eyes thoroughly with water to remove. Stop use and ask a physician if rash or irritation develops and lasts. Store away from excessive heat and direct sun.

OTC - PURPOSE SECTION

Sun screen

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

DOSAGE & ADMINISTRATION SECTION

Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least every 2 hours. For children under 6 months, ask a physician.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Yes. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - ACTIVE INGREDIENT SECTION

Octocrylene

Ethylhexyl Methoxycinnamate

Oxybenzone

Avobenzone

INACTIVE INGREDIENT SECTION

Purified Water

Propylene Glycol Diethylhexanoate

Dimethicone

PVP/Eicosene Copolymer

Stearic Acid

Cetyl Phosphate

Glycerin

Benzyl Alcohol

Cetyl Alcohol

Carbomer 1342

Triethanolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Solbar Fifty.jpg image description

SOLBAR FIFTY SPF50 
solbar fifty spf50 cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0096-0741
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.1 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.08 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.06 g  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.011 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL DIETHYLHEXANOATE (UNII: 8D8I9Z0F1Z)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
EICOSYL POVIDONE (2 EICOSYL BRANCHES/REPEAT) (UNII: XQQ9MKE2BJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
GLYCERIN (UNII: PDC6A3C0OX)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CARBOMER 1342 (UNII: 809Y72KV36)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0096-0741-04128 g in 1 BOTTLE; Type 0: Not a Combination Product06/01/1996
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/1996
Labeler - Person and Covey (008482473)
Establishment
NameAddressID/FEIBusiness Operations
Person and Covey008482473manufacture(0096-0741)

Revised: 10/2022
Document Id: ec08b2fe-995c-71ae-e053-2995a90a9651
Set id: 41fd3844-181c-4cb2-8379-f313104351ef
Version: 13
Effective Time: 20221027
 
Person and Covey