DAY C- avobenzone octinoxate oxybenzone cream

DAY C by

Drug Labeling and Warnings

DAY C by is a Otc medication manufactured, distributed, or labeled by Kamins Dermatologics Inc., Odan Laboratories Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients:

AVOBENZONE 2 %

OCTINOXATE 7 %

OXYBENZONE 5 %

PURPOSE

Purpose: Sunscreen

KEEP OUT OF REACH OF CHILDREN

Keep out of the 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

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 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

B. KAMINS

DAY CREAM SPF15

50mL / 1.7 fl.oz

DIN 0246708

INGREDIENTS AND APPEARANCE

DAY C 
avobenzone octinoxate oxybenzone cream

Product 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) , pack(63550-120)