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made of Broad Spectrum SPF 30 Non-Nano Zinc Oxide Sunscreen

Medically reviewed by Drugs.com. Last updated on Sep 5, 2017.

Dosage form: lotion
Ingredients: ZINC OXIDE 20g in 100mL
Labeler: MADEOF, LLC
NDC Code: 71439-050

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.

made of ® Broad Spectrum SPF 30 Non-Nano Zinc Oxide Sunscreen

Drug Facts

Active Ingredient

Non-Nano Uncoated Zinc Oxide 20.0%

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. Rinse with water to remove.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions
  • Diretions for full protection, apply liberally (2mg/cm2) to all exposed skin 15 minutes before sun exposure then rub it in to reduce whitening effect.

Reapply:

  • After 40 minutes of swimming or sweating • Immediately after towel drying. • At least every two 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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10am-2pm
    • Wear long-sleeved shirts, pants, hats, and sunglasses
  • For children under six months of age ask a doctor.

Ingredients

Helianthus Annuus* (Sunflower) Oil, Cocos Nucifera* (Coconut) Oil, Cera Alba* (Beeswax), Theobroma Cacao* (Cocoa) Seed Butter, Vanilla Oil* (Vanilla), Tocopherol*, Argania Spinosa Leaf* (Argan) Oil, Rubus Ideaus* (Raspberry) Seed Oil
*=Certified Organic

Other information:

Store at temperatures below 90°F

PRINCIPAL DISPLAY PANEL - 118 ml Tube

made of ®
Broad Spectrum Sunscreen

SPF 30
Water Resistant (80 minutes)

79% Certified Organic Ingredients

21% Natural

NSF

Non GMO

Soy Free

Nut Free

Pediatrician Tested

Dermatologist Tested

4 fl.oz (118 ml)

MADE OF BROAD SPECTRUM SPF 30 NON-NANO ZINC OXIDE SUNSCREEN 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71439-050
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE20 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
VANILLA PLANIFOLIA OIL 
ARGAN OIL 
RASPBERRY SEED OIL 
TOCOPHEROL 
COCOA BUTTER 
COCONUT OIL 
SUNFLOWER OIL 
YELLOW WAX 
Packaging
#Item CodePackage Description
1NDC:71439-050-161 TUBE in 1 CARTON
1118 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/05/2017
Labeler - MADEOF, LLC (080635957)

 
MADEOF, LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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