Protection U.V. Broad Spectrum SPF 25

Protection U.V. Broad Spectrum SPF 25

Drug Labeling and Warnings

Drug Details

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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
[email protected]
www.biologique-recherche.us


CANADA
THE PRINCIPLES BRANDS
349 St.Clair Ave West, Suite 104
TORONTO, ON M5P 1N3
416-464-8852
[email protected]
www.theprinciplebrands.com

Package Labeling:

Outer PackageInner Package

PROTECTION U.V. BROAD SPECTRUM SPF 25 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69332-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE25 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION38 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69332-001-501 in 1 CARTON11/02/2014
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 69332-001-001 in 1 CARTON11/02/2014
2100 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 69332-001-044 mL in 1 TUBE; Type 0: Not a Combination Product06/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/02/2014
Labeler - B.R. (296150530)
Establishment
NameAddressID/FEIBusiness Operations
B.R.296150530manufacture(69332-001)

Revised: 1/2020
 
B.R.


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