BEAUTY BY EARTH® - SPF 30 - PEPPERMINT & VANILLA

BEAUTY BY EARTH - SPF 30 - PEPPERMINT AND VANILLA by

Drug Labeling and Warnings

BEAUTY BY EARTH - SPF 30 - PEPPERMINT AND VANILLA by is a Otc medication manufactured, distributed, or labeled by Pro Skin Solutions, Inc. DBA Active Cosmetics Manufacturing. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BEAUTY BY EARTH - SPF 30 - PEPPERMINT AND VANILLA- zinc oxide spray 
Pro Skin Solutions, Inc. DBA Active Cosmetics Manufacturing

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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BEAUTY BY EARTH® - SPF 30 - PEPPERMINT & VANILLA

DRUG FACTS

Active Ingredients

Zinc Oxide (Non-nano) 18%

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.

Stop use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Shake well before use  Do not spray directly on face  Spray into hands and apply to face  Spray directly onto body and rub in  Apply liberally 15 minutes before sun exposure.

Reapply: After 40 minutes of swimming or sweating 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.

Inactive Ingredients

Caprylic/Capric Triglyceride (Fractionated Coconut Oil), Coco-Caprylate, Olea Europaea (Squalane) Oil, Octyldodecanol, Water (Aqua), Triethyl Citrate, Shea Butter Ethyl Esters, *Mentha Piperita (Peppermint) Oil, *Vanilla Planifolia Fruit Extract, *Santalum Album (Sandalwood) Oil, Cetyl Phosphate, Microcrystalline Cellulose, Cellulose Gum, Tocopherol (Sunflower Derived Vitamin E) 
*Certified Organic Ingredients

Questions?

Call (469) 777-6501 or email support@beautybyearth.com

Mineral Sunscreen

With Transparent Zinc Oxide

VEGAN INGREDIENTS

inspire beauty, naturally

Our sunscreen spray is gentle, yet effective. A light formulation that works for even the most sensitive skin. It provides a quick and easy application for children and adults alike.

Manufactured for and distributed by:
Beauty by Earth Flower Mound, TX 75028
www.beautybyearth.com

© Beauty by Earth. All rights reserved.

Made in the USA.

Packaging

Packaging

BEAUTY BY EARTH - SPF 30 - PEPPERMINT AND VANILLA 
zinc oxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 15464-0020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
SQUALANE (UNII: GW89575KF9)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
WATER (UNII: 059QF0KO0R)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SHEA BUTTER ETHYL ESTERS (UNII: V2CI786FPG)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
VANILLA BEAN (UNII: Q74T35078H)  
SANDALWOOD OIL (UNII: X7X01WMQ5F)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 15464-0020-11 in 1 BOX11/25/2021
1177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/25/2021
Labeler - Pro Skin Solutions, Inc. DBA Active Cosmetics Manufacturing (174120506)
Establishment
NameAddressID/FEIBusiness Operations
Pro Skin Solutions, Inc. DBA Active Cosmetics Manufacturing174120506manufacture(15464-0020)

Revised: 11/2021
 
Pro Skin Solutions,

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