OTC Medication Information: LASPA Ultra Sun Stick

LASPA ULTRA SUN STICK- zinc oxide stick
Vegewax Caldeworx 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.

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

Label
(click image for full-size original)

LASPA ULTRA SUN STICK
spf 50 broad spectrum mineral sunscreen stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:44114-550
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CASTOR OIL
YELLOW WAX
TITANIUM DIOXIDE
JOJOBA OIL, RANDOMIZED
CHOLECALCIFEROL
SILICON DIOXIDE
ROSEMARY
BROWN IRON OXIDE
SUNFLOWER OIL
TOCOPHEROL
COCONUT OIL
COCOA BUTTER
CARNAUBA WAX
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:44114-550-14 14 g in 1 TUBE None
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 Caldeworx Ltd (201050882)
Establishment
Name Address ID/FEI Operations
Vegewax Caldeworx Ltd 201050882 manufacture (44114-550)

Revised: 06/2021 Vegewax Caldeworx Ltd

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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