COOLA Mineral Liplux Lip Balm SPF 30 - Nude Beach

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]

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

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.

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COOLA Mineral Liplux Lip Balm SPF 30 - Nude Beach

Titanium Dioxide 3.6%

Zinc Oxide 3.0%

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.

  • 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. 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.

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

Protect this product from excessive heat and direct sun.

Call 760-940-2125

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COOLA MINERAL LIPLUX LIP BALM SPF 30 NUDE BEACH 
titanium dioxide, zinc oxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 79753-055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.6 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 79753-055-011 in 1 CARTON02/01/2019
14.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02002/01/2019
Labeler - COOLA, LLC (956990290)

Revised: 11/2022

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