DESERT BAMBU SUNSCREEN SPF 30- octinoxate, octocrylene, oxybenzone, and titanium dioxide lotion

Desert Bambu by

Drug Labeling and Warnings

Desert Bambu by is a Otc medication manufactured, distributed, or labeled by Lifetech Resources, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENTS

Octinoxate 7.0 %, Octocrylene 6.5 % Oxybenzone 5.5 %, Titanium Dioxide 4.5 %

PURPOSE

Sunscreen

USE

Helps prevent sunburn. Higher SPF gives more sunburn protection.

DIRECTIONS

Apply evenly and liberally to all exposed areas before sun exposure. Ensure complete coverage. Reapply as needed or after swimming, towel drying, perspiring, or vigorous activity. Ask a doctor before use on children under 6 months of age.

WARNINGS

For external use only.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

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

INACTIVE INGREDIENTS

Water, C12-15 Alkyl Benzoate, Butylene Glycol, Cyclopentasiloxane, Acrylates Copolymer, Stearyl Alcohol, Dimethicone, Cetearyl Alcohol, Ceteareth-20, Potassium Cetyl Phosphate , Polysorbate 60, Cetearyl Methicone, Aloe Barbadensis Leaf Extract, Tocopheryl Acetate, Calendula Officinalis Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Alumina, Polyhydroxystearic Acid, Isopropyl Titanium Triisostearate/Triethoxycaprylylsilane Crosspolymer, Xanthan Gum, Citric Acid, Iodopropynyl Butylcarbamate, DMDM Hydantoin

PRINCIPAL DISPLAY PANEL - 148 mL Tube Label

desert
BAMBŪ®
sunscreen lotion
SPF 30

148 mL e 5 Fl. Oz.

INGREDIENTS AND APPEARANCE

DESERT BAMBU  SUNSCREEN SPF 30
octinoxate, octocrylene, oxybenzone, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65643-419
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	73.50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	68.25 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	57.75 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	47.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Dimethicone (UNII: 92RU3N3Y1O)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Polysorbate 60 (UNII: CAL22UVI4M)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
.Alpha.-Tocopherol Acetate, D- (UNII: A7E6112E4N)
Calendula Officinalis Flower (UNII: P0M7O4Y7YD)
Chamomile (UNII: FGL3685T2X)
Aluminum Oxide (UNII: LMI26O6933)
Xanthan Gum (UNII: TTV12P4NEE)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)
DMDM Hydantoin (UNII: BYR0546TOW)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65643-419-10	148 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2008

Labeler - Lifetech Resources, LLC (622559110)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources, LLC		622559110	MANUFACTURE