BAMBO NATURE SUNNY DAY- titanium dioxide cream 
DermaPharm A/S

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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Active Ingredient

Titanium Dioxide 8.46%

Purpose

Sunscreen

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

Directions

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 value of 15 or higher and other sun protection measures including:

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.

Inactive ingredients

Aloe Barbadensis Leaf Extract*, Alumina, Caprylic/Capric Triglyceride, Glycerin**, Magnesium Sulfate, Polyglyeryl-2 Dipolyhydroxystearate, Polyglyeryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Water.

*Ingredients from organic farming

**Made using organic ingredients

label

BAMBO NATURE SUNNY DAY 
titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24959-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.46 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24959-001-01150 g in 1 BOTTLE; Type 0: Not a Combination Product06/01/2017
2NDC:24959-001-0230 g in 1 BOTTLE; Type 0: Not a Combination Product06/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35206/01/2017
Labeler - DermaPharm A/S (306036476)
Establishment
NameAddressID/FEIBusiness Operations
DermaPharm A/S306036476manufacture(24959-001)

Revised: 6/2017
Document Id: 5160be3d-d432-6577-e054-00144ff8d46c
Set id: 5160be3d-d431-6577-e054-00144ff8d46c
Version: 1
Effective Time: 20170607
 
DermaPharm A/S