SP-FB0D-L0TNBARRIERPROTECTIONMINERALSUNSCREEN- barrier protection mineral sunscreen lotion

Drug Labeling and Warnings

Drug Details [pdf]

Active Ingredient

Active Ingredient

Zinc Oxide (non-nano)

Purpose

Active Ingredients Purpose

Zinc Oxide (non-nano) 15%.....Sunscreen

Uses

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

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

Directions

Apply generously 15 minutes before sun exposure
Reapply
After 40 minutes of swimming or sweating
Immediately after towel drying
At least every 2 hours
Children under 6 months: 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, 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 10:00 a.m. – 2 p.m.

Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Inactive Ingredients

Caprylic/Capric Triglyceride, Carthamus Tinctorius (Safflower) Seed Oil, *Ricinus Communis (Castor) Seed Oil, Hydrogenated Castor Oil, Isodecyl Neopentanoate, Maranta Arundinacea Root (Arrowroot) Extract, Diisopropyl Sebacate, Lauryl Lactate, *Argania Spinosa (Argan) Kernel Oil, *Simmondsia Chinensis (Jojoba) Seed Oil, Tocopherol (Sunflower Derived), Heptyl Undecylenate, Squalane, Persea Gratissima (Avocado) Oil, *Butyrospermum Parkii (Shea) Butter, Aroma (Naturally Derived), Polyhydroxystearic Acid, Bentonite, Glyceryl Undecylenate

*Certified Organic Ingredients

Other Information

Other Information Protect this product from excessive heat and direct sun.

OTC - Questions Section

Questions? Call (469) 777-6501 or email info@beautybyearth.com

Dosage & Administration

Directions

apply liberally and evenly 15 minutes before sun exposure
apply to all skin exposed to the sun
reapply:

after 80 minutes of swimming or sweating
immediately after towel drying
at least every 2 hours

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, 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

Indications & Usage

Indications & Usage

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

Keep out of reach of children

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SP-FB0D-L0TNBARRIERPROTECTIONMINERALSUNSCREEN 
barrier protection mineral sunscreen lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87623-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)	29 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87623-0002-2	130 g in 1 TUBE; Type 0: Not a Combination Product	04/27/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/27/2026

Labeler - Epic Etailers, LLC (DBA: Beauty by Earth) (015153345)

Registrant - Naturich Cosmetique Labs (124281663)

Establishment
Name	Address	ID/FEI	Business Operations
Naturich Cosmetique Labs		124281663	manufacture(87623-0002)