OTC Medication Information: Made of Broad Spectrum SPF 30 Non-Nano Zinc Oxide Sunscreen

MADE OF BROAD SPECTRUM SPF 30 NON-NANO ZINC OXIDE SUNSCREEN- zinc oxide lotion
MADEOF, 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.

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)

Sunscreen box
(click image for full-size original)
Sunscreen Label
(click image for full-size original)
MADE OF BROAD SPECTRUM SPF 30 NON-NANO ZINC OXIDE SUNSCREEN
zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71439-050
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 20 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
VANILLA PLANIFOLIA OIL
ARGAN OIL
RASPBERRY SEED OIL
TOCOPHEROL
COCOA BUTTER
COCONUT OIL
SUNFLOWER OIL
YELLOW WAX
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71439-050-16 1 TUBE in 1 CARTON contains a TUBE
1 118 mL in 1 TUBE This package is contained within the CARTON (71439-050-16)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 09/05/2017
Labeler — MADEOF, LLC (080635957)

Revised: 01/2020 MADEOF, LLC

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.

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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