DAILY ESSENTIAL MOISTURISER by INTERNATIONAL WATERS PTY. LTD. / Baxter Laboratories Pty. Ltd. Drug Facts

DAILY ESSENTIAL MOISTURISER by

Drug Labeling and Warnings

DAILY ESSENTIAL MOISTURISER by is a Otc medication manufactured, distributed, or labeled by INTERNATIONAL WATERS PTY. LTD., Baxter Laboratories Pty. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DAILY ESSENTIAL MOISTURISER- homosalate, octisalate, avobenzone, octocrylene, oxybenzone lotion 
INTERNATIONAL WATERS PTY. LTD.

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.

----------

Drug Facts

Active Ingredients:

Homosalate 10%

Octisalate   5%

Avobenzone  4%

Octocrylene  2%

Oxybenzone  4%

Purpose:

Homosalate 10% ..........Sunscreen

Octisalate   5% ............Sunscreen

Avobenzone  4% ..........Sunscreen

Octocrylene  2% ..........Sunscreen

Oxybenzone  4% ..........Sunscreen

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away.

Use: Sunscreen

Directions: Apply liberally 15 minutes before sun exposure, Reapply at least every 2 hours

Warnings:

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. his product has been shown only ot prevent sunburn, not skin cancer or early skin aging

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove

Stop use and ask doctor if rash occurs

Keep out of reach of children If swallowed get medical help or contact a Poison Control Center
right away.

Dosage and Administration:

Apply liberally 15 minutes before sun exposure

Use a water resistant Sunscreen if swimming or sweating

Reapply at least every 2 hours.

Children under 6 months: Ask a doctor

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cera Alba, Hydroxyethylcellulose, Isopropyl Myristate, Methylparaben,  Paraffinum Liquidum, PEG-15 Cocamine, PEG-40 stearate, Phenoxyethanol, Propylparaben, Silica, Tocopherol, Triethanolamine, Water

DAILY ESSENTIAL MOISTURISER 
homosalate, octisalate, avobenzone, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55528-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	40 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
WHITE WAX (UNII: 7G1J5DA97F)
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-15 COCAMINE (UNII: 8L6LB12TSJ)
PEG-40 STEARATE (UNII: ECU18C66Q7)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TOCOPHEROL (UNII: R0ZB2556P8)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55528-001-50	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2013	11/18/2019
2	NDC: 55528-001-30	30 mL in 1 TUBE; Type 0: Not a Combination Product	01/15/2013	11/18/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/15/2013	11/18/2019

Labeler - INTERNATIONAL WATERS PTY. LTD. (754473957)

Establishment
Name	Address	ID/FEI	Business Operations
Baxter Laboratories Pty. Ltd.		740537709	manufacture(55528-001)

Revised: 12/2019

Document Id: bc495e74-9bbb-4b6f-b02a-2100be3266d5

34390-5

Set id: 8505aca7-f28b-4159-8d82-eac2b128e4e0

Version: 2

Effective Time: 20191218

 

INTERNATIONAL WATERS PTY. LTD.