DAY HYDRATOR SPF-15- octinoxate and octisalate and oxybenzone lotion

DAY HYDRATOR by

Drug Labeling and Warnings

DAY HYDRATOR by is a Otc medication manufactured, distributed, or labeled by 220 Laboratories Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

Ethylhexyl Methoxycinnamate - 7.5%
Ethylhexyl Salicylate - 5.0%
Benzophenone-3 - 3.0%

DOSAGE & ADMINISTRATION

DIRECTIONS: In the morning, gently apply a small amount of moisturizer onto clean face and neckfor daily hydration and skin protection.

GENERAL PRECAUTIONS

CAUTION: Discontinue use if redness or rash occurs. Seek medical attention if irritation persists.

WARNINGS

WARNING: For external use only.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

GiGi ORGANICS
Natural Skincare System

DAY HYDRATOR
SPF 15

Honey
Sunflower
Green Tea

INGREDIENTS AND APPEARANCE

DAY HYDRATOR  SPF-15
octinoxate and octisalate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57367-027
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 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 100 STEARATE (UNII: YD01N1999R)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
TROLAMINE (UNII: 9O3K93S3TK)
MYRISTYL LAURATE (UNII: 58U0NZN2BT)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE SODIUM (UNII: MP1J8420LU)
HELIANTHUS ANNUUS (UNII: BKJ0J3D1BP)
ORANGE OIL (UNII: AKN3KSD11B)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PANTHENOL (UNII: WV9CM0O67Z)
HONEY (UNII: Y9H1V576FH)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
BELLIS PERENNIS (UNII: 2HU33I03UY)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
HIBISCUS SABDARIFFA CALYX (UNII: 584J2XT260)
JASMINE (UNII: 0Q8K841432)
LAVENDER (UNII: 9YT4B71U8P)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57367-027-19	1 in 1 CARTON
1	NDC: 57367-027-18	56 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2006

Labeler - 220 Laboratories Inc. (783247950)

Registrant - 220 Laboratories Inc. (783247950)

Establishment
Name	Address	ID/FEI	Business Operations
220 Laboratories Inc.		783247950	manufacture