BOSCIA DAILY DEFENSE SUNSCREEN BROAD SPECTRUM SPF 50 PA- octinoxate, titanium dioxide, zinc oxide cream

Boscia Daily Defense Sunscreen Broad Spectrum SPF 50 PA by

Drug Labeling and Warnings

Boscia Daily Defense Sunscreen Broad Spectrum SPF 50 PA by is a Otc medication manufactured, distributed, or labeled by Boscia LLC, Englewood Lab, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Boscia Daily Defense Sunscreen Broad Spectrum SPF 50 PA

Active Ingredients

Octinoxate  7.25%
Titanium Dioxide 5.74%
Zinc Oxide  4.75%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging  caused by the sun.
  

Warnings

For external use only.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes.  Rinse with water to remove.

Stop use and ask a doctor

if rash occurs.

Keep out of reach of children

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply liberally 15 minutes before sun exposure
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Optional: apply to all skin exposed to the sun
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease this risk regularly use a sunscreen with a broadspectrum SPF of 15 or higher and another sun protection measures including:
• Limit time in the usn, especially from 10 a.m. - 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months:  Ask a doctor

Inactive Ingredients:

Cyclopentasiloxane, Water/Aqua/Eau, PEG-10 Dimethicone, Butylene Glycol, Glycerin, Caprylyl Methicone, Isodecyl Neopentanoate, Methylcellulose, Aluminum Starch Octenylsuccinate, Disteardimonium Hectorite, Sodium Chloride, Alumina, Dipropylene Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Camellia Oleifera Leaf Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Dipotassium Glycyrrhizate, Sodium Hyaluronate, Tocopheryl Acetate, Panthenol, Sodium Levulinate, Sodium PCA, Methicone, Sodium Anisate, Silica, Caprylyl Glycol.

Other information

• protect this product from excessive heat and sun
  

Questions or comments?

Call toll free 1-888-635-8884

SPL UNCLASSIFIED SECTION

This dual-action, anti-aging formula absorbs quickly for maximum protection. Titanium Dioxide, Zinc Oxide and Octinoxate absorb UVA and UVB rays to prevent skin damage. Hygroscopic (water storing) ingredients Sodium PCA, Pre Vitamin B5 and Hylauronic Acid help certain moisture. Green Tea Extract and Vitamin E Acetate deliver antioxidant benefits to help prevent free radical damage while nourishing skin.

Preservative-free.  Artificial fragrance and color free.  Gluten-free.  Ethanol alcohol-free.  Dermatologist tested.      www.boscia.net   B212-01   Distributed by   boscia, LLC.  Irvine, CA 92614    Made in USA

PRINCIPAL DISPLAY PANEL

boscia   Daily Defense Sunscreen Broad Spectrum SPF 50 PA+++ For all skin types    1.7 oz / 50 g

Product Labels

INGREDIENTS AND APPEARANCE

BOSCIA DAILY DEFENSE SUNSCREEN BROAD SPECTRUM SPF 50 PA 
octinoxate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76151-241
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.25 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	5.742 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	4.75 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ALUMINUM OXIDE (UNII: LMI26O6933)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
DIMETHICONE (UNII: 92RU3N3Y1O)
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
JOJOBA OIL (UNII: 724GKU717M)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM LEVULINATE (UNII: VK44E1MQU8)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
SODIUM ANISATE (UNII: F9WFJ28MV9)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76151-241-01	50 g 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	11/07/2012

Labeler - Boscia LLC (967960951)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab, Inc.		080366903	manufacture(76151-241)

Establishment
Name	Address	ID/FEI	Business Operations
Englewood Lab Korea Co., Ltd.		690104005	manufacture(76151-241)