OIL-FREE DAILY HYDRATION SPF 15- octinoxate, avobenzone cream

Oil-Free Daily Hydration SPF 15 by

Drug Labeling and Warnings

Oil-Free Daily Hydration SPF 15 by is a Otc medication manufactured, distributed, or labeled by Boscia LLC, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients       Purpose
Octinoxate 5%           Sunscreen
Avobenzone 3%         Sunscreen

PURPOSE

Use Helps prevent sunburn.

WARNINGS

Warnings For external use only.

WHEN USING

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

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTHER SAFETY INFORMATION

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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.

DESCRIPTION

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OIL-FREE DAILY HYDRATION SPF 15 
octinoxate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76151-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
ROSEMARY (UNII: IJ67X351P9)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
POTASSIUM PHOSPHATE (UNII: B7862WZ632)
CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)
ZINC OXIDE (UNII: SOI2LOH54Z)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76151-105-52	15 mL in 1 TUBE; Type 0: Not a Combination Product	12/19/2017
2	NDC: 76151-105-11	40 mL in 1 TUBE; Type 0: Not a Combination Product	12/19/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/16/2011

Labeler - Boscia LLC (967960951)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(76151-105)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(76151-105)