Bella Blu Skin Care Non Tinted Sunscreen — v1

Bella Blu Skin Care Non Tinted Sunscreen

8 Views

Version

v1

Effective date

September 22, 2025

Original packager

Yes

Sections captured

10

Identifiers

Document ID
3f66d2ae-00e8-608c-e063-6294a90a49c6
Set ID
3f66d2ae-00e7-608c-e063-6294a90a49c6
Application numbers
M020
Product NDCs
87099-205
Package NDCs
87099-205-04
Original packager NDCs
—

Names & Manufacturers

Brand names
Bella Blu Skin Care Non Tinted Sunscreen
Generic names
ZINC OXIDE
Manufacturer names
BELLA BLU STUDIOS 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
0387099205043

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active Ingredients: Zinc Oxide 20%
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: C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water
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

Bella Blu Skin Care Non Tinted Sunscreen Zinc Oxide C12-15 ALKYL BENZOATE CYCLOHEXASILOXANE EDETATE DISODIUM ANHYDROUS HYDROGEN DIMETHICONE (20 CST) DIMETHICONOL (2000 CST) DIMETHICONE CROSSPOLYMER POLYGLYCERYL-4 ISOSTEARATE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) DIMETHICONE TETRAHEXYLDECYL ASCORBATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) GLYCERIN PEG-10 DIMETHICONE (600 CST) ALPHA-TOCOPHEROL ACETATE POLYHYDROXYSTEARIC ACID (2300 MW) TRIETHANOLAMINE TRIETHOXYCAPRYLYLSILANE WATER PEG-30 DIPOLYHYDROXYSTEARATE CAPRYLHYDROXAMIC ACID MICROCRYSTALLINE WAX STEARYL DIMETHICONE (400 MPA.S AT 50C) CAPRYLYL GLYCOL CYCLOPENTASILOXANE SODIUM CHLORIDE ZINC OXIDE ZINC OXIDE POLYSORBATE 20
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': ['Bella Blu Skin Care Non Tinted Sunscreen'],
 'generic_name': ['ZINC OXIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['BELLA BLU STUDIOS INC'],
 'package_ndc': ['87099-205-04'],
 'product_ndc': ['87099-205'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['3f66d2ae-00e8-608c-e063-6294a90a49c6'],
 'spl_set_id': ['3f66d2ae-00e7-608c-e063-6294a90a49c6'],
 'substance_name': ['ZINC OXIDE'],
 'unii': ['SOI2LOH54Z'],
 'upc': ['0387099205043']}