SOLBAR FIFTY SPF50 cream

Solbar Fifty SPF50 by

Drug Labeling and Warnings

Solbar Fifty SPF50 by is a Otc medication manufactured, distributed, or labeled by Person and Covey. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SOLBAR FIFTY SPF50 
solbar fifty spf50 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0096-0741
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.1 g  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.08 g  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.06 g  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.011 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0096-0741-04	128 g in 1 BOTTLE; Type 0: Not a Combination Product	06/01/1996

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	06/01/1996

Labeler - Person and Covey (008482473)

Establishment
Name	Address	ID/FEI	Business Operations
Person and Covey		008482473	manufacture(0096-0741)