DAY C- avobenzone octinoxate oxybenzone cream 
Kamins Dermatologics Inc.

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.

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CONSUMER LABELING

Active ingredients:


AVOBENZONE 2 %



OCTINOXATE 7 %


OXYBENZONE 5 %

Purpose: Sunscreen

Keep out of the reach of children.

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

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.





Directions

Apply liberally and evenly each morning to cleansed face and neck, before sun exposure and as needed. reapply after swimming, washing/towel drying or perspiring heavily.

Children under 6 months of age: ask a doctor.




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

B. KAMINS

DAY CREAM SPF15

50mL / 1.7 fl.oz

DIN 0246708

Day Cream SPF15 front panel image

DAY C 
avobenzone octinoxate oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63550-120-0350 g in 1 BOX; Type 0: Not a Combination Product10/01/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/01/2003
Labeler - Kamins Dermatologics Inc. (254050784)
Registrant - Kamins Dermatologics Inc. (254050784)
Establishment
NameAddressID/FEIBusiness Operations
Odan Laboratories Ltd208585604manufacture(63550-120) , pack(63550-120)

Revised: 12/2020
Document Id: b623979c-baed-c704-e053-2a95a90a9452
Set id: 505b59f9-9203-467c-af39-95f7087c9288
Version: 6
Effective Time: 20201210
 
Kamins Dermatologics Inc.