Label: DAILY FACIAL MOISTURIZER- octinoxate, octisalate, avobenzone lotion
- NDC Code(s): 50594-995-26
- Packager: BIG LOTS
- 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.
Drug Label Information
Updated May 1, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
- Do not use
- Stop use and ask a doctor if
- When using this product
- 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 higher 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
water, diisopropyl adipate, cyclomethicone, glycerin, undecylcrylene dimethicone, glyceryl stearate, PET-100 stearate, polymethyl methacrylate, phenoxyethanol, benzyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, tocopyeryl acetate, carbomer, disodium EDTA, trietanoolamine, potassium sorbate
-
SPL UNCLASSIFIED SECTION
*This product is not manufactured or distributed by Galderma Laboratories, LP, distributor of Cetaphil Daily Facial Moistrizer SPF 15
Retain carton for complete information about thsi product.
May stain or damage some fabric or surfaces.
Manufactured for
Big Lots Stores, Inc.
By: Vi-Jon, Inc.
8515 Page Avenue
St. Louis, MO 63114
- Principal Panel Display
-
INGREDIENTS AND APPEARANCE
DAILY FACIAL MOISTURIZER
octinoxate, octisalate, avobenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50594-995 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) DIISOPROPYL ADIPATE (UNII: P7E6YFV72X) CYCLOMETHICONE (UNII: NMQ347994Z) GLYCERIN (UNII: PDC6A3C0OX) UNDECYLCRYLENE DIMETHICONE (10000 MW) (UNII: HA26P2LA4P) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) METHYL METHACRYLATE (UNII: 196OC77688) PHENOXYETHANOL (UNII: HIE492ZZ3T) BENZYL ALCOHOL (UNII: LKG8494WBH) CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO) TOCOPHEROL (UNII: R0ZB2556P8) CARBOMER 940 (UNII: 4Q93RCW27E) EDETATE DISODIUM (UNII: 7FLD91C86K) TRIETHANOLAMINE LACTATE (UNII: 064C51N81O) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50594-995-26 1 in 1 CARTON 02/25/2017 1 141 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/25/2017 Labeler - BIG LOTS (017885351) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(50594-995) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(50594-995)
