Label: DAY C- avobenzone octinoxate oxybenzone cream
- NDC Code(s): 63550-120-03
- Packager: Kamins Dermatologics Inc.
- Category: HUMAN OTC DRUG LABEL
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 December 1, 2022
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 INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
-
INDICATIONS & USAGE
This light weight, non-greasy day cream preserves your skin with a healthier protective shield, essential nutrients and continuous moisture release suited to a multitude of daytime environmental conditions. Our Bio-maple technology helps fight the look of wrinkles, moisturizes and provides radiance throuhout the day. A perfect primer for mak-up. For maximum benefits, may be reapplied over make-up as often as needed. Also useful for soothing post-microdermabrasion skin.
Uses
helps prevent sunburn
higher SPF gives more sunburn protection
provides moderate protection against sunburn
-
WARNINGS
Warnings
For external use only.
When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.
Stop use and ask a doctor if rash or irritation develops and lasts.
If swallowed, seek medical assistance or contact a Poison Control Center immediately.
Sun alert: limiting sun exposure, earing protective clothing and using sunscreens may reduce the risks of skin aging, skin cancer and other harmful effects of the sun.
- DOSAGE & ADMINISTRATION
-
INACTIVE INGREDIENT
Inactive ingredients:
aqua/water/eau, glyceryl stearate SE, soluble collagen, butylene glycol, acer saccharum (maple isolate), cetyl alcohol, ceteareth-12, coco-caprylate/caprate, squalane, magnesium aluminum silicate, cyclotetrasiloxane, cyclopentasiloxane, PEG/PPG-18/18 dimethicone, PEG-16 soy sterol, dimethicone, polysorbate 80, prunus armeniaca (apricot) kernel oil, retinyl palmitate, tocopheryl acetate, sodium hydroxide, citric acid, phenoxyethanol, caprylyl glycol, sorbic acid, parfum/fragrance. Contains oxybenzone
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DAY C
avobenzone octinoxate oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63550-120 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 70 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ACER SACCHARUM SAP (UNII: 75UOH57984) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW) (UNII: ZR28QKN0WT) OCTOCRYLENE (UNII: 5A68WGF6WM) CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETEARETH-12 (UNII: 7V4MR24V5P) CYCLOMETHICONE 4 (UNII: CZ227117JE) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) DIMETHICONE (UNII: 92RU3N3Y1O) COCO-CAPRYLATE (UNII: 4828G836N6) POLYSORBATE 80 (UNII: 6OZP39ZG8H) CARBOMER 934 (UNII: Z135WT9208) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBIC ACID (UNII: X045WJ989B) SQUALANE (UNII: GW89575KF9) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) APRICOT KERNEL OIL (UNII: 54JB35T06A) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63550-120-03 50 g in 1 BOX; Type 0: Not a Combination Product 10/01/2003 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/01/2003 Labeler - Kamins Dermatologics Inc. (254050784) Registrant - Kamins Dermatologics Inc. (254050784) Establishment Name Address ID/FEI Business Operations Odan Laboratories Ltd 208585604 manufacture(63550-120)
