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DAY HYDRATOR SPF-15

Dosage form: lotion
Ingredients: OCTINOXATE 75mg in 1g, OCTISALATE 50mg in 1g, OXYBENZONE 30mg in 1g
Labeler: 220 Laboratories Inc.
NDC Code: 57367-027

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.

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



DAY HYDRATOR  SPF-15
octinoxate and octisalate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57367-027
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE75 mg  in 1 g
OCTISALATE (OCTISALATE) OCTISALATE50 mg  in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ETHYLHEXYL PALMITATE 
PROPYLENE GLYCOL 
GLYCERYL MONOSTEARATE 
CETOSTEARYL ALCOHOL 
POLYOXYL 100 STEARATE 
STEARIC ACID 
DIMETHICONE 
CAPRYLYL GLYCOL 
MYRISTYL MYRISTATE 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
HEXYLENE GLYCOL 
TROLAMINE 
MYRISTYL LAURATE 
ALLANTOIN 
EDETATE SODIUM 
HELIANTHUS ANNUUS 
ORANGE OIL 
BUTYLENE GLYCOL 
PANTHENOL 
HONEY 
CALENDULA OFFICINALIS FLOWER 
BELLIS PERENNIS 
GREEN TEA LEAF 
HIBISCUS SABDARIFFA CALYX 
JASMINE 
LAVENDER 
ROSA CANINA FRUIT 
PHENOXYETHANOL 
Packaging
#Item CodePackage Description
1NDC:57367-027-191 TUBE (TUBE) 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/FEIOperations
220 Laboratories Inc.783247950manufacture

Revised: 05/2010
Document Id: de535765-6fa3-4715-9dcc-037f6dc80577
Set id: 23a8e7af-802b-48a0-93b9-a3665a12254b
Version: 2
Effective Time: 20100510
 
220 Laboratories Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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