LANOCREME HYDRATING DAY SPF15

Dosage form: cream
Ingredients: AVOBENZONE 1.5g in 50g, OXYBENZONE 1.5g in 50g, OCTINOXATE 7.5g in 50g
Labeler: Lanocorp Pacific Ltd
NDC Code: 43617-3415

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
Avobenzone 3%
Oxybenzone 3%
Octylmethoxycinnamate 7.5%

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

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.

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.

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

Stop use and ask a doctor if any rush occurs.

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




LANOCREME HYDRATING   DAY SPF15
avobenzone, oxybenzone, octyl methoxycinnamate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43617-3415
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE ) AVOBENZONE 1.5 g  in 50 g
OXYBENZONE (OXYBENZONE) OXYBENZONE1.5 g  in 50 g
OCTINOXATE (OCTINOXATE) OCTINOXATE7.5 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:43617-3415-11 JAR (JAR) in 1 BOX
150 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/30/2012
Labeler - Lanocorp Pacific Ltd (594482114)
Establishment
NameAddressID/FEIOperations
Lanocorp Pacific Ltd594482114manufacture

Revised: 04/2012
 
Lanocorp Pacific Ltd

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 combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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