Label: SOLBAR AVO SPF35 cream
- NDC Code(s): 0096-0687-04
- Packager: Person and Covey
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated October 27, 2022
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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.
- Keep out of the reach of children
- Dosage and Administration
- OTC - ACTIVE INGREDIENT SECTION
- INACTIVE INGREDIENT SECTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
SOLBAR AVO SPF35
solbar avo spf35 cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0096-0687 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 0.08 g in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 0.075 g in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 0.06 g in 1 g AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 0.03 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOBUTYL STEARATE (UNII: V8DPR6HNX3) GLYCERIN (UNII: PDC6A3C0OX) BENZYL ALCOHOL (UNII: LKG8494WBH) CETYL PHOSPHATE (UNII: VT07D6X67O) TROLAMINE (UNII: 9O3K93S3TK) STEARIC ACID (UNII: 4ELV7Z65AP) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CARBOMER 1342 (UNII: 809Y72KV36) (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8) EDETATE DISODIUM (UNII: 7FLD91C86K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0096-0687-04 119 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(0096-0687)