Vegewax Candleworx Ltd. 44114-520-12 44114-520-50

LASPA by

Drug Labeling and Warnings

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

Drug Details [pdf]

LASPA- spf 20 broad spectrum mineral sunscreen lotion 
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.

44114-520-12
44114-520-50

Zinc Oxide 15%

Sunscreen

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. 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.

use a water resistance sunscreen if swimming or sweating

reapply:

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

Water, Helianthus Annuus (Sunflower) Seed Oil*, Glycerin, Glyceryl Stearate, Vitis Vinifera (Grape) Seed Oil, Cetearyl Alcohol, Sorbitan Sesquioleate, Crambe Abyssinica Seed Oil, Glyceryl Caprylate, Butyrospermum Parkii (Shea) Butter, Tocopherol, Xanthan Gum, Glyceryl Undecylenate, Iron Oxides

*Certified Organic

125 mL

50g

LASPA 
spf 20 broad spectrum mineral sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44114-520
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GRAPE SEED OIL (UNII: 930MLC8XGG)
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
WATER (UNII: 059QF0KO0R)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
BROWN IRON OXIDE (UNII: 1N032N7MFO)
SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
SHEA BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44114-520-50	50 mL in 1 TUBE; Type 0: Not a Combination Product	06/07/2021
2	NDC: 44114-520-12	125 mL in 1 TUBE; Type 0: Not a Combination Product	06/07/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/07/2021

Labeler - Vegewax Candleworx Ltd (201050882)

Establishment
Name	Address	ID/FEI	Business Operations
Vegewax Candleworx Ltd		201050882	manufacture(44114-520)

Revised: 11/2021

Document Id: d20c8fe9-2ee9-edad-e053-2995a90a2364

34390-5

Set id: c3e257cd-a4af-63d6-e053-2a95a90a6eec

Version: 3

Effective Time: 20211130