Oil-Free Daily Hydration SPF 15

Dosage form: cream
Ingredients: OCTINOXATE 5mL in 100mL, AVOBENZONE 3mL in 100mL
Labeler: Boscia LLC
NDC Code: 76151-105

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.

Oil-Free Daily Hydration SPF 15

Active Ingredients       Purpose
Octinoxate 5%           Sunscreen
Avobenzone 3%         Sunscreen

Use Helps prevent sunburn.

Warnings For external use only.

Avoid direct contact with eyes. If contact occurs, rinse gently with water.

Discontinue use and consult a physician immediately if any adverse reaction occurs.

Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions  Apply small amount in AM to cleansed and toned face as last skincare step.

Inactive Ingredients: Water, Butylene Glycol, Silica, Glycerin, Polyglyceryl-10 Stearate, Pentylene Glycol, Simmondsia Chinensis (Jojoba) Leaf Extract, Epilobium Angustifolium Flower/leaf/stem Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Algae Extract, Hydrolyzed Yeast Extract, Arctium Lappa Root Extract, Phellodendron Amurense Bark Extract, Hydrogenated Rapeseed Alcohol, Hydroxyethylcellulose, Sclerotium Gum, Aluminum Hydroxide, Potassium Phosphate, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Zinc Oxide, Titanium Dioxide.

Preservative-free.  Dermatologist tested.  Non-comedogenic.  Alcohol-free, pH balanced, 100% natural fragrance and color, no animals testing and no animal ingredients.    An oil-free moisturizer that hydrates the skin, minimizes pores and providers broad spectrum SPF 15.  Polysaccharide provides essential moisture, silica powder controls excessive oil while wine Yeast and Marine Complex help protect against external elements.  www.boscia.net  B105-11  Distributed by  boscia LLC. Irvine, CA 92614  Made in Japan   U8-2

boscia  Oil-free  Daily Hydration  SPF 15  For normal to oily skin  Preservative-free  1.4 fl oz/40 ml

www.boscia.net  B105-11  Distributed by  boscia LLC. Irvine, CA 92614  Made in Japan   U8-2

OIL-FREE DAILY HYDRATION SPF 15 
octinoxate, avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76151-105
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE5 mL  in 100 mL
AVOBENZONE (AVOBENZONE) AVOBENZONE3 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
SILICON DIOXIDE 
GLYCERIN 
PENTYLENE GLYCOL 
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP 
ROSEMARY 
ARCTIUM LAPPA ROOT 
PHELLODENDRON AMURENSE BARK 
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) 
ALUMINUM HYDROXIDE 
POTASSIUM PHOSPHATE 
CITRUS AURANTIUM FLOWER 
ZINC OXIDE 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:76151-105-5215 mL in 1 TUBE
2NDC:76151-105-1140 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/16/2011
Labeler - Boscia LLC (967960951)
Establishment
NameAddressID/FEIOperations
Englewood Lab, LLC172198223manufacture

Revised: 04/2011
 
Boscia LLC

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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