TROPICAL LIP BALM SPF 15- octinoxate, oxybenzone stick

Tropical Lip Balm by

Drug Labeling and Warnings

Tropical Lip Balm by is a Otc medication manufactured, distributed, or labeled by Natural Star Labs, Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

ACTIVE INGREDIENT

Active Ingredients:
Octinoxate 2.0%

Oxybenzone 4.5%

PURPOSE

Purpose

Octinoxate ........Sunscreen
Oxybenzone ......Sunscreen

INDICATIONS & USAGE

Uses: Helps prevent sunburn Helps prevent and
temporarily protect dry, chapped or windburned lips.

WARNINGS

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun
increases your risk of skin cancer and early skin aging. This
product has been shown only to prevent sunburn, not skin
cancer or early aging.

OTHER SAFETY INFORMATION

For external use only

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions: Apply liberally before sun exposure and as
needed.
Children under 6 months of age: Ask a doctor before use.

INACTIVE INGREDIENT

Inactive ingredients: Synthetic Beeswax, Helianthus
Annuus (Sunflower) Seed Oil, Ricinus Communis (Castor)
Seed Oil, Lanolin, Cocos Nucifera (Coconut) Oil, Flavor,
Zea Mays (Corn) Oil, Tocopheryl Acetate, BHT.

PRINCIPAL DISPLAY PANEL

PEEL HERE FOR DRUG FACTS               Qxxxxxxx

Broad Spectrum SPF 15 Sunscreen
Tropical Lip Balm                            Net Wt. 0.15 oz (4.25g)

Dist. by: www. totallypromotional.com | Coldwater, OH 45828

SAFETY
SEAL

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INGREDIENTS AND APPEARANCE

TROPICAL LIP BALM  SPF 15
octinoxate, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52060-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.50 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
LANOLIN (UNII: 7EV65EAW6H)
COCONUT OIL (UNII: Q9L0O73W7L)
CORN OIL (UNII: 8470G57WFM)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52060-009-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product	10/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	10/07/2019

Labeler - Natural Star Labs, Ltd (078493787)

Registrant - Natural Star Labs, Ltd (078493787)