PROTECTION U.V. BROAD SPECTRUM SPF 25- titanium dioxide, zinc oxide cream

Protection U.V. Broad Spectrum SPF 25 by

Drug Labeling and Warnings

Protection U.V. Broad Spectrum SPF 25 by is a Otc medication manufactured, distributed, or labeled by B.R.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

TITANIUM DIOXIDE  2.5 %

ZINC OXIDE  3.8%

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 of contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure
reapply:
after 40 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours
  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 broad spectrum SPF of 15 or higher and other sun protection measures including:
limit time in the sun, 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

Algae Extract, Alumina, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carnosine, Diatomaceous Earth, Dicaprylyl Carbonate, Ethyl Ferulate,
Ethylhexylglycerin, Glycerin, Isostearic Acid, Laminaria Ochroleuca Extract, Lecithin, Magnesium Sulfate, Mannitol, Octyldodecanol, Octyldodecyl Xyloside, Oryzanol, PEG-30 Dipolyhydroxystearate, PEG-8 Laurate, Pentylene Glycol, Phaeodactylum Tricornutum Extract, Phenoxyethanol, Polyamide-5, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Pongamia Glabra Seed Oil, Silybum Marianum Fruit Extract, Stearic Acid, Styrene/ Acrylates Copolymer, Tocopherol, Water (Aqua), Xanthan Gum, Zinc Sulfate.

Other information

• protect this product from excessive heat and direct sun

Questions or comments?

USA
BIOLOGIQUE RECHERCHE
261 Fifth Avenue, Suite 2000
NY 10016 New York USA
1-212-989-6077
usa@biologique-recherche.com
www.biologique-recherche.us

CANADA
THE PRINCIPLES BRANDS
349 St.Clair Ave West, Suite 104
TORONTO, ON M5P 1N3
416-464-8852
info@theprinciplesbrands.com
www.theprinciplebrands.com

Package Labeling:

INGREDIENTS AND APPEARANCE

PROTECTION U.V. BROAD SPECTRUM SPF 25 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69332-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	25 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	38 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARNOSINE (UNII: 8HO6PVN24W)
DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ETHYL FERULATE (UNII: 5B8915UELW)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
ISOSTEARIC ACID (UNII: X33R8U0062)
LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
MANNITOL (UNII: 3OWL53L36A)
OCTYLDODECANOL (UNII: 461N1O614Y)
GAMMA ORYZANOL (UNII: SST9XCL51M)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
PEG-8 LAURATE (UNII: 762O8IWA10)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
KARUM SEED OIL (UNII: 62160PU6FJ)
MILK THISTLE (UNII: U946SH95EE)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC SULFATE (UNII: 89DS0H96TB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69332-001-50	1 in 1 CARTON	11/02/2014
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 69332-001-00	1 in 1 CARTON	11/02/2014
2		100 mL in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 69332-001-04	4 mL in 1 TUBE; Type 0: Not a Combination Product	06/06/2017	10/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/02/2014

Labeler - B.R. (296150530)

Establishment
Name	Address	ID/FEI	Business Operations
B.R.		296150530	manufacture(69332-001)