DAY HYDRATOR SPF-15- octinoxate and octisalate and oxybenzone lotion 
220 Laboratories 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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DAY HYDRATOR SPF-15 ARTWORK

ACTIVE INGREDIENTS:

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

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

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

WARNING: For external use only.

KEEP OUT OF REACH OF CHILDREN.

GiGi ORGANICS
Natural Skincare System

DAY HYDRATOR
SPF 15

Honey
Sunflower
Green Tea
GiGi SPF-15 Hydrator Tube Artwork
GiGi SPF-15 Hydrator UC Artwork



DAY HYDRATOR  SPF-15
octinoxate and octisalate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57367-027
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57367-027-191 in 1 CARTON
1NDC:57367-027-1856 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/2006
Labeler - 220 Laboratories Inc. (783247950)
Registrant - 220 Laboratories Inc. (783247950)
Establishment
NameAddressID/FEIBusiness Operations
220 Laboratories Inc.783247950manufacture

Revised: 5/2010
Document Id: de535765-6fa3-4715-9dcc-037f6dc80577
Set id: 23a8e7af-802b-48a0-93b9-a3665a12254b
Version: 2
Effective Time: 20100510
 
220 Laboratories Inc.