Vegewax Candleworx Ltd 44114-551-14

LASPA Ultra Sun Stick by

Drug Labeling and Warnings

LASPA Ultra Sun Stick by is a Otc medication manufactured, distributed, or labeled by Vegewax Candleworx Ltd, Vegewax Caldeworx Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LASPA ULTRA SUN STICK- pf 50 broad spectrum mineral sunscreen stick 
Vegewax Candleworx Ltd

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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Vegewax Candleworx Ltd
44114-551-14

Description

Drug Facts

Active ingredients

Titanium dioxide 3.8% Sunscreen

Zinc Oxide 25%

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.

Retains SPF after 80 minutes of: activity in water, sweating, perspiring.

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

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

Directions

apply generously and evenly 15 minutes before sun exposure.

children under 6 months of age: Ask a doctor.

reapply:

after 80 minutes of swimming or sweating,

immediately after towel drying.

at least every 2 hours

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.

Other information

protect the product in this container from excessive heat and direct sun.

for further information please call 1-877-476-2758

Inactive ingredients

Ricinus Communis (Castor) Seed Oil*, Helianthus Annuus (Sunflower) Seed Oil*, Beeswax/Cera Alba/Cire d’abeille*, Cocos Nucifera (Coconut) Oil*, Theobroma Cacao (Cocoa) Seed Butter*, Silica, Jojoba esters, Copernicia Cerifera (Carnauba) Wax/Cera Carnauba/Cire de carnauba*, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract*, Cholecalciferol, Iron Oxides (CI 77491)

LASPA ULTRA SUN STICK 
pf 50 broad spectrum mineral sunscreen stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44114-551
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
COCONUT OIL (UNII: Q9L0O73W7L)
CASTOR OIL (UNII: D5340Y2I9G)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)
COCOA BUTTER (UNII: 512OYT1CRR)
ROSEMARY (UNII: IJ67X351P9)
YELLOW WAX (UNII: 2ZA36H0S2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44114-551-14	14 g in 1 TUBE; Type 1: Convenience Kit of Co-Package	11/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/30/2021

Labeler - Vegewax Candleworx Ltd (201050882)

Establishment
Name	Address	ID/FEI	Business Operations
Vegewax Caldeworx Ltd		201050882	manufacture(44114-551)

Revised: 11/2021

Document Id: d20c884b-afe1-a8d8-e053-2a95a90a05b1

34390-5

Set id: d20b9ec5-ef6d-6482-e053-2a95a90a89ac

Version: 2

Effective Time: 20211130