Label: OCTINOXATE, OCTISALATE, AVOBENZONE lotion
- NDC Code(s): 41250-863-26
- Packager: Meijer Distribution, Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated August 21, 2024
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
-
Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- 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 highter and other sun protection measures including:
- limit the 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
- Principal Panel Display
-
INGREDIENTS AND APPEARANCE
OCTINOXATE, OCTISALATE, AVOBENZONE
octinoxate, octisalate, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-863 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) GLYCERIN (UNII: PDC6A3C0OX) UNDECYLCRYLENE DIMETHICONE (10000 MW) (UNII: HA26P2LA4P) CANDELILLA WAX (UNII: WL0328HX19) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PEG-100 STEARATE (UNII: YD01N1999R) DIMETHICONE (UNII: 92RU3N3Y1O) TRIETHANOLAMINE LACTATE (UNII: 064C51N81O) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) ETHYLPARABEN (UNII: 14255EXE39) PROPYLPARABEN (UNII: Z8IX2SC1OH) CARBOMER 1342 (UNII: 809Y72KV36) EDETATE SODIUM (UNII: MP1J8420LU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-863-26 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/25/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/25/2013 Labeler - Meijer Distribution, Inc (006959555) Registrant - Consumer Product Partners, LLC (119091520) Establishment Name Address ID/FEI Business Operations Consumer Product Partners, LLC 119091514 manufacture(41250-863)