BAMBO NATURE SUNNY DAY- titanium dioxide cream

Bambo Nature Sunny Day by

Drug Labeling and Warnings

Bambo Nature Sunny Day by is a Otc medication manufactured, distributed, or labeled by Abena North America, Inc., DermaPharm A/S. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Titanium Dioxide 8.46%

PURPOSE

Purpose

Sunscreen

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

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

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

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 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

INGREDIENTS AND APPEARANCE

BAMBO NATURE SUNNY DAY 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71466-001
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: 71466-001-01	150 g in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2017
2	NDC: 71466-001-02	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 - Abena North America, Inc. (078740398)

Establishment
Name	Address	ID/FEI	Business Operations
DermaPharm A/S		306036476	manufacture(71466-001)