Label: BAMBO NATURE SUNNY DAY- titanium dioxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 24959-001-01, 24959-001-02 - Packager: DermaPharm A/S
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 7, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Directions
- Apply liberally and evenly 15 minutes before sun exposure
- Reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours
- Children under 6 months: ask a doctor
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:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- WARNINGS
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INACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BAMBO NATURE SUNNY DAY
titanium dioxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24959-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 8.46 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:24959-001-01 150 g in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2017 2 NDC:24959-001-02 30 g in 1 BOTTLE; Type 0: Not a Combination Product 06/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/01/2017 Labeler - DermaPharm A/S (306036476) Establishment Name Address ID/FEI Business Operations DermaPharm A/S 306036476 manufacture(24959-001)
