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

By Nature Hydrating by

Drug Labeling and Warnings

By Nature Hydrating by is a Otc medication manufactured, distributed, or labeled by Lanocorp Pacific Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS
Avobenzone 3%
Oxybenzone 3%
Octylmethoxycinnamate 7.5%

INDICATIONS & USAGE

USES
Helps prevent sunburn

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

PURPOSE

Sunscreen

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.5 g  in 50 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 50 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Ethylhexyl palmitate (UNII: 2865993309)
Tricaprylin (UNII: 6P92858988)
Tricaprin (UNII: O1PB8EU98M)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Laureth-7 (UNII: Z95S6G8201)
Polysorbate 60 (UNII: CAL22UVI4M)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glycerin (UNII: PDC6A3C0OX)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Cyclomethicone 4 (UNII: CZ227117JE)
Dimethiconol (41 MPA.S) (UNII: 343C7U75XW)
Caprylhydroxamic acid (UNII: UPY805K99W)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylpropanediol (UNII: N8F53B3R4R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Lanolin (UNII: 7EV65EAW6H)
Sorbitan monostearate (UNII: NVZ4I0H58X)
HYDROLYSED MARINE COLLAGEN (ENZYMATIC; 2000 MW) (UNII: 2WID9OCG7P)
EDETATE SODIUM (UNII: MP1J8420LU)
KIWI FRUIT (UNII: 71ES77LGJC)
HONEY (UNII: Y9H1V576FH)

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

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

Labeler - Lanocorp Pacific Ltd (594482114)

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