OTC Medication Information: Eco Lips Zinc Sunscreen Lip Balm Broad Spectrum SPF 15 Coconut Vanilla

ECO LIPS ZINC SUNSCREEN LIP BALM BROAD SPECTRUM SPF 15 COCONUT VANILLA- zinc oxide stick
Eco Lips. Inc.

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

Zinc Oxide 20%

Purpose

Sunscreen

Use

helps prevent sunburn

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.

Directions for Sunscreen Use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water-resistant sunscreen if swimming or sweating.
  • children under 6 months of age: ask a doctor
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk
  • limit time in the sun, especially from 10 a.m. — 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses

Other information

protect this product from excessive heat and direct sun

Inactive ingredients

*Olea Europaea (Olive) Fruit Oil, *Cera Flava (Beeswax), *†Cocos Nucifera (Coconut) Oil, *†Theobroma Cacao (Cocoa) Seed Butter, *Coconut Flavor, *Copernical Cerifera (Carnauba) Wax, *Vanilla Flavor, Mixed Tocopherols (Vitamin E).

*Organic Ingredient † Fair Trade Certified™ by Fair Trade USA 20% of Product

Questions or comments?

1-866-326-5477

ECO LIPS, INC. | CEDAR RAPIDS, IA 52402

ECOLIPS.COM

MANUFACTURED IN USA

CERTIFIED TO NSF/ANSI 305 BY OREGON TILTH

ECO LIPS®

ZINC

BROAD SPECTRUM SPF 15

SUNSCREEN LIP BALM

COCONUT VANILLA

Moisturize and protect with olive oil, coconut oil & cocoa butter.

Coral Reef Safe

Net Wt. .15 oz (4.25g)

Zinc Coconut Van PDP
(click image for full-size original)
Zinc Coconut Van DF
(click image for full-size original)
ECO LIPS ZINC SUNSCREEN LIP BALM BROAD SPECTRUM SPF 15 COCONUT VANILLA
zinc oxide stick
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75071-004
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 g
Inactive Ingredients
Ingredient Name Strength
CARNAUBA WAX
VANILLA
OLIVE OIL
YELLOW WAX
COCOA BUTTER
TOCOPHEROL
COCONUT OIL
Product Characteristics
Color Score
Shape Size
Flavor COCONUT, VANILLA Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75071-004-01 1 TUBE in 1 BLISTER PACK contains a TUBE
1 4.25 g in 1 TUBE This package is contained within the BLISTER PACK (75071-004-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final M020 04/01/2021
Labeler — Eco Lips. Inc. (138732727)
Establishment
Name Address ID/FEI Operations
Eco Lips, Inc. 138732727 manufacture (75071-004)

Revised: 08/2022 Eco Lips. Inc.

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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