Non-Tinted Replenishing Daily Protection — v1

Non-Tinted Replenishing Daily Protection

5 Views

Version

v1

Effective date

September 22, 2025

Original packager

Yes

Sections captured

10

Identifiers

Document ID
3f69d6f3-454c-e60a-e063-6394a90a8781
Set ID
3f69d6f3-454b-e60a-e063-6394a90a8781
Application numbers
M020
Product NDCs
87122-226
Package NDCs
87122-226-50
Original packager NDCs
—

Names & Manufacturers

Brand names
Non-Tinted Replenishing Daily Protection
Generic names
ZINC OXIDE
Manufacturer names
MADRE TIERRA, INC.
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
ZINC OXIDE
Routes
TOPICAL
Pharmacologic class (PE)
—
Pharmacologic class (EPC)
—
Pharmacologic class (CS)
—
Mechanism of action
—

Other identifiers

NUI
—
RxCUI
—
UNII
SOI2LOH54Z
UPC
—

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active Ingredients: Zinc Oxide 16%
Dosage And Administration (1)

Sequence 1

Directions: Apply liberally 15 minutes before sun exposure. Use a water-resistant product if swimming or sweating. Reapply 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 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses.
Inactive Ingredient (1)

Sequence 1

Inactive Ingredients: Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydrogen Dimethicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer
Indications And Usage (1)

Sequence 1

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.
Keep Out Of Reach Of Children (1)

Sequence 1

Warnings: Keep out of reach of children
Other Safety Information (1)

Sequence 1

Other Information: Protect this product from excessive heat and direct sun
Package Label Principal Display Panel (1)

Sequence 1

Package Label
Purpose (1)

Sequence 1

Purpose: Sunscreen
Spl Product Data Elements (1)

Sequence 1

Non-Tinted Replenishing Daily Protection Zinc Oxide DIMETHICONE CYCLOPENTASILOXANE POLYHYDROXYSTEARIC ACID (2300 MW) .ALPHA.-TOCOPHEROL ACETATE ZINC OXIDE ZINC OXIDE DIMETHICONOL (2000 CST) HYDROGEN DIMETHICONE (20 CST) CYCLOHEXASILOXANE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) PEG-10 DIMETHICONE (600 CST) VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER TETRAHEXYLDECYL ASCORBATE CAPRYLIC/CAPRIC TRIGLYCERIDE CERAMIDE 3 DIMETHICONE CROSSPOLYMER
Warnings (1)

Sequence 1

Warnings: For external use only. Do not use on broken or damaged skin. Stop use and ask a doctor if rash occurs. 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.

OpenFDA raw payload

{'application_number': ['M020'],
 'brand_name': ['Non-Tinted Replenishing Daily Protection'],
 'generic_name': ['ZINC OXIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['MADRE TIERRA, INC.'],
 'package_ndc': ['87122-226-50'],
 'product_ndc': ['87122-226'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['3f69d6f3-454c-e60a-e063-6394a90a8781'],
 'spl_set_id': ['3f69d6f3-454b-e60a-e063-6394a90a8781'],
 'substance_name': ['ZINC OXIDE'],
 'unii': ['SOI2LOH54Z']}