BY NATURE HYDRATING DAY SPF 15- avobenzone , oxybenzone and octinoxate cream
Lanocorp Pacific 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.

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Drug Facts

ACTIVE INGREDIENTS
Avobenzone 3%
Oxybenzone 3%
Octylmethoxycinnamate 7.5%

USES
Helps prevent sunburn

WARNINGS
For external use only. Do not use on broken or damaged skin.
Skin Cancer/Skin Ageing Alert: Spending time in the sun increases your risk of skin cancer and early skin ageing. This product has been shown only to help prevent sunburn, not skin cancer or early skin ageing.

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

Stop use and ask a doctor if any rush occurs.

Keep out of reach of children.
Keep out of reach of children. If product is swalowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS
Apply liberally and evenly 15 minutes before sun exposure
Children under 6 months of age: Ask a doctor
Apply to all skin exposed to the sun
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating

ACTIVE INGREDIENTS
Avobenzone 3%
Oxybenzone 3%
Octyl methoxycinnamate 7.5%

Sunscreen

INACTIVE INGREDIENTS
Water
Ethylhexyl palmitate
Caprylic triglyceride
Capric triglyceride
Polyacrylamide
c13-14 Isoparaffin
Laureth-7
Polysorbate 60
Cetearyl alcohol
Glycerin
Cyclopentasiloxane
Clyclotetrasiloxane
dimethiconol
Caprylhydroxamic acid
phenoxyethanol
methylpropanediol
tocopheryl acetate (vitamin e)
lanolin (medical grade)
Sorbitan stearate
Hydrolyzed (Marine) collagen
Tetrasodium EDTA
Actinidia chinensis (kiwi) fruit extract
Leptospermum scoparium Mel UMF 15+ Active Manuka Honey

By Nature Hydrating Cream Outer

BY NATURE HYDRATING DAY SPF 15
avobenzone, oxybenzone, octyl methoxycinnamate cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:43617-3416
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (AVOBENZONE )	AVOBENZONE	1.5 g in 50 g
OXYBENZONE (OXYBENZONE)	OXYBENZONE	1.5 g in 50 g
OCTINOXATE (OCTINOXATE)	OCTINOXATE	7.5 g in 50 g

Ingredient Name	Strength
Inactive Ingredients
Water
Ethylhexyl palmitate
Tricaprylin
Tricaprin
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)
C13-14 Isoparaffin
Laureth-7
Polysorbate 60
Cetostearyl Alcohol
Glycerin
Cyclomethicone 5
Cyclomethicone 4
Dimethiconol (41 MPA.S)
Caprylhydroxamic acid
Phenoxyethanol
Methylpropanediol
ALPHA-TOCOPHEROL ACETATE
Lanolin
Sorbitan monostearate
HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW)
EDETATE SODIUM
KIWI FRUIT
HONEY

#	Item Code	Package Description
Packaging
1	NDC:43617-3416-2	1 in 1 BOX
1		60 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	08/01/2012

Labeler - Lanocorp Pacific Ltd (594482114)

Name	Address	ID/FEI	Business Operations
Establishment
Lanocorp Pacific Ltd		594482114	manufacture(43617-3416)

Revised: 8/2012

Document Id: 908f17ea-085b-4f6a-a9d2-6f96cfd495ff

Set id: b57d984c-c3f7-4ce2-82b9-905769a55617

Version: 1

Effective Time: 20120829

Lanocorp Pacific Ltd