SOLBAR SHIELD SPF40 cream

Solbar Shield SPF40 by

Drug Labeling and Warnings

Solbar Shield SPF40 by is a Otc medication manufactured, distributed, or labeled by Person and Covey. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Indications and use

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 and Administration: 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.

Purpose

Sunscreen

Keep out of the reach of children

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

Dosage and Administration

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.

Warnings

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 - ACTIVE INGREDIENT SECTION

Homosalate

Octinoxate

Oxybenzone

Avobenzone

INACTIVE INGREDIENT SECTION

Water

Isobutyl Stearate

Glycerin

Benzyl Alcohol

Simethicone

Cetyl Phosphate

Triethanolamine

Stearic Acid

Silica

Carbomer 1342

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Disodium EDTA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SOLBAR SHIELD SPF40 
solbar shield spf40 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0096-0682
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.05 g  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.075 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DIETHANOLAMINE OLETH-3 PHOSPHATE (UNII: Y67NX5905E)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOBUTYL STEARATE (UNII: V8DPR6HNX3)
CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0096-0682-04	129 g in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2000

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(0096-0682)