Wonderscreen Tinted Broad Spectrum SPF 30 — v3

Wonderscreen Tinted Broad Spectrum SPF 30

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Version

v3

Effective date

October 1, 2025

Original packager

Yes

Sections captured

9

Identifiers

Document ID
401d6a89-6195-f287-e063-6294a90aca43
Set ID
f2a59fa4-f19c-a15f-e053-2a95a90a6ace
Application numbers
M020
Product NDCs
82870-005
Package NDCs
82870-005-01
Original packager NDCs
—

Names & Manufacturers

Brand names
Wonderscreen Tinted Broad Spectrum SPF 30
Generic names
ZINC OXIDE
Manufacturer names
Dime Beauty Co, LLC
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 Ingredient: Zinc Oxide 19.0% Purpose: Sunscreen
Dosage And Administration (1)

Sequence 1

Directions: Apply Liberally 15 minutes before sun or water exposure Immediately after towel drying At least every 2 hours Children under 6 months: Ask a doctor.
Inactive Ingredient (1)

Sequence 1

Inactive Ingredients: Water, Ethylhexyl Olivate, Dimethicone, C9-12 Alkane, Cocoglycerides, Hydroxyethyl Dimethicone Laurate, Pentylene Glycol, Butyloctyl Salicylate, Glycerin, Jojoba Esters, Pyrus Malus (Apple) Fruit Extract, Polymethylsilsesquioxane Diheptyl Succinate , Disteardimonium Hectorite, Squalane, Simmondisa (Jojoba) Seed Oil, Phenoxyethanol, Sodiium Chloride, Iron Oxides (CI 77492), Polyhydroxystearic Acid, Trihydroxystearin, Triethyl Citrate, Hydroxyacetophenone, Dipotassium Glycyrrhizate, Sodium Citrate, Beta Vulgaris (Beet) Root Extract Fructooligosaccharides, Iron Oxides (CI 77491), Iron oxides (CI 77499), Tetrasodium Glutamate Diacetate, Sodium Dehydroacetate, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica, Glycine Soja (Soybean) Seed Extract, Polyglyceryl-6 Polyricinoleate
Indications And Usage (1)

Sequence 1

Stop use and ask a doctor if rash occurs.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

Dime Wonderscreen Tinted Broad Spectrum SPF 30 50 G tinted wonderscreen glass pump Tinted wonderscreen carton
Purpose (1)

Sequence 1

Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection.
Spl Product Data Elements (1)

Sequence 1

Wonderscreen Tinted Broad Spectrum SPF 30 Zinc Oxide SILICON DIOXIDE CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) SODIUM CITRATE SOYBEAN APPLE DISTEARDIMONIUM HECTORITE BEET GLYCERIN TRIETHYL CITRATE GLYCYRRHIZINATE DIPOTASSIUM SQUALANE DIHEPTYL SUCCINATE POLYGLYCERYL-6 POLYRICINOLEATE PHENOXYETHANOL FERRIC OXIDE YELLOW JOJOBA OIL POLYHYDROXYSTEARIC ACID (2300 MW) FERRIC OXIDE RED FERROSOFERRIC OXIDE TRIHYDROXYSTEARIN TETRASODIUM GLUTAMATE DIACETATE HYDROXYACETOPHENONE PENTYLENE GLYCOL SODIUM CHLORIDE ZINC OXIDE ZINC OXIDE WATER DIMETHICONE COCO-GLYCERIDES BUTYLOCTYL SALICYLATE JOJOBA OIL, RANDOMIZED POLYMETHYLSILSESQUIOXANE (11 MICRONS) SODIUM DEHYDROACETATE
Warnings (1)

Sequence 1

Warning: For external use only . Do not use on broken or damaged skin. When using this product keep out of eyes. Rinse with water to remove.

OpenFDA raw payload

{'application_number': ['M020'],
 'brand_name': ['Wonderscreen Tinted Broad Spectrum SPF 30'],
 'generic_name': ['ZINC OXIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Dime Beauty Co, LLC'],
 'package_ndc': ['82870-005-01'],
 'product_ndc': ['82870-005'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['401d6a89-6195-f287-e063-6294a90aca43'],
 'spl_set_id': ['f2a59fa4-f19c-a15f-e053-2a95a90a6ace'],
 'substance_name': ['ZINC OXIDE'],
 'unii': ['SOI2LOH54Z']}