Label: AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE lotion
- NDC Code(s): 0869-0711-34
- Packager: Vi-Jon, LLC
- 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 May 11, 2021
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- Active Ingredients
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children
- apply liberally 15 minutes before sun exposure
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: Ask a doctor
- Other information
- Inactive ingredients
SPL UNCLASSIFIED SECTION
May stain or damage some fabrics or surfaces
*This product is not manufactured or distributed by Bayer, distributor of Coppertone Ultra Guard Sunscreen Lotion Broad Spectrum SPF 50.
Made in the USA with US and foreign parts.
Manufactured by: Vi-Jon, LLC St. Louis, MO 63114
Questions or Comments? 1-888-593-0593
- principal display panel
INGREDIENTS AND APPEARANCE
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0869-0711 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30.9 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 133.9 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 51.5 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 72.1 mg in 1 mL oxybenzone (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) oxybenzone 41.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) TROLAMINE (UNII: 9O3K93S3TK) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) STEARIC ACID (UNII: 4ELV7Z65AP) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) BENZYL ALCOHOL (UNII: LKG8494WBH) DIMETHICONE (UNII: 92RU3N3Y1O) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) CHLORPHENESIN (UNII: I670DAL4SZ) POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0869-0711-34 236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/12/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/12/2016 Labeler - Vi-Jon, LLC (790752542) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(0869-0711)