COOLA MINERAL LIPLUX LIP BALM SPF 30 NUDE BEACH- titanium dioxide, zinc oxide stick

COOLA Mineral Liplux Lip Balm SPF 30 Nude Beach by

Drug Labeling and Warnings

COOLA Mineral Liplux Lip Balm SPF 30 Nude Beach by is a Otc medication manufactured, distributed, or labeled by COOLA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 3.6%

Zinc Oxide 3.0%

PURPOSE

Sunscreen

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.

WARNINGS

• For external use only.
• Do not use on damaged or broken skin.
• When using this product keep out of eyes.
• Stop use and ask doctor if skin rash occurs

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.

Directions

• Apply liberally 15 minutes before sun exposure & again after 80 minutes of swimming or sweating.
• Apply at least every 2 hours.
• Sun Protection Measures - To decrease your risk of cancer and early skin aging, 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. to 2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses.

INACTIVE INGREDIENT

Cocos Nucifera (Coconut) Oil (ORGANIC), Olea Europaea (Olive) Fruit Oil (ORGANIC), Copernicia Cerifera (Carnauba) Wax (ORGANIC), Persea Gratissima (Avocado) Oil (ORGANIC), Octyldodecyl Oleate, Jojoba Esters, Butyrospermum Parkii (Shea) Butter (ORGANIC), Schinziophyton Rautanenii Kernel Oil (ORGANIC), Flavor, Theobroma Cacao (Cocoa) Seed Butter (ORGANIC), Hydrogenated Castor Oil, Theobroma Grandiflorum Seed Butter (ORGANIC), Octyldodecyl PCA, Helianthus Annuus (Sunflower) Seed Wax, Acacia Decurrens Flower Wax, Polyglycerin-3, Rosmarinus Officinalis (Rosemary) Leaf Extract (ORGANIC), Helianthus Annuus (Sunflower) Seed Oil (ORGANIC), Polyhydroxystearic Acid, C18-38 Alkyl Hydroxystearoyl Stearate, Stevia Rebaudiana Extract, Silica, Iron Oxides, Mica

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

QUESTIONS

Call 760-940-2125

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOLA MINERAL LIPLUX LIP BALM SPF 30 NUDE BEACH 
titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79753-055
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICA (UNII: V8A1AW0880)
ROSEMARY (UNII: IJ67X351P9)
SHEA BUTTER (UNII: K49155WL9Y)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
SUNFLOWER OIL (UNII: 3W1JG795YI)
C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM)
STEVIA REBAUDIANA WHOLE (UNII: 6U422Y08O2)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
SCHINZIOPHYTON RAUTANENII SEED OIL (UNII: 6GSJ7A6T1E)
THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
OLIVE OIL (UNII: 6UYK2W1W1E)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
OCTYLDODECYL PCA (UNII: E25TY46YTD)
FERRIC OXIDE RED (UNII: 1K09F3G675)
COCONUT OIL (UNII: Q9L0O73W7L)
CARNAUBA WAX (UNII: R12CBM0EIZ)
AVOCADO OIL (UNII: 6VNO72PFC1)
COCOA BUTTER (UNII: 512OYT1CRR)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79753-055-01	1 in 1 CARTON	02/01/2019
1		4.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/01/2019

Labeler - COOLA, LLC (956990290)