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

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.

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Protection U.V. Broad Spectrum SPF 25

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:

Outer Package Inner Package

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:69332-001-50	1 in 1 CARTON	11/02/2014	09/30/2020
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:69332-001-00	1 in 1 CARTON	11/02/2014	09/30/2020
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	11/02/2014	09/30/2020

Labeler - B.R. (296150530)

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

Revised: 12/2022

Document Id: eff7d269-5ba5-361f-e053-2995a90a3f02

Set id: 93cad677-7883-4812-9a4a-0261b3113765

Version: 9

Effective Time: 20221216

B.R.