DAY L- avobenzone octisalate octinoxate lotion

DAY L by

Drug Labeling and Warnings

DAY L 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 2.5 %

OCTINOXATE 7.5 %

OCTISALATE 4.0 %

PURPOSE

Purpose: Sunscreen

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

INDICATIONS & USAGE

A LIGHT, SILKY LOTION THAT DIFFUSES A BLEND OF MOISTURIZERS, ANTI-OXYDANT VOTMINS INTO THE SKIN TO ENHANCE DAY LONG COMFORT AND HYDRATION. THE SKIN'S OUTER LAYERS ARE COVERED WITH A PROTECTIVE SHIELD, PRODUCING A HEALTHY, LUMINESCENT GLOW. 

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.

DOSAGE & ADMINISTRATION

Directions:

Apply liberally and evenly each morning to cleansed face and neck, before sun exposure and as needed.

Children under 6 months of age: ask a doctor.

INACTIVE INGREDIENT

Inactive ingredients:

aqua/water/eau, acer saccharum (maple isolate), butylene glycol, hydrolyzed collagen, hydrolyzed elastin, octocrylene, cetyl alcohol, glyceryl stearate SE, ceteareth-12, cyclotetrasiloxane, cyclopentasiloxane, PEG/PPG-18/18 dimethicone, coco- caprylate/caprate, polysorbate-80, carbomer, tocopheryl acetate, retinyl palmitate, sodium hydroxide, phenoxyethanol, caprylyl glycol, sorbic acid, parfum/fragrance

PRINCIPAL DISPLAY PANEL

B. KAMINS

DAY LOTION SPF15

50mL / 1.7 fl.oz

DIN 02248016

INGREDIENTS AND APPEARANCE

DAY L 
avobenzone octisalate octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63550-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63550-122-03	50 mL in 1 BOX; Type 0: Not a Combination Product	03/01/2004

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/01/2004

Labeler - Kamins Dermatologics Inc. (254050784)

Registrant - Kamins Dermatologics Inc. (254050784)

Establishment
Name	Address	ID/FEI	Business Operations
Odan Laboratories Ltd		208585604	manufacture(63550-122) , pack(63550-122)