Wonderscreen Tinted Broad Spectrum SPF 30 Shade 3 — v4

Wonderscreen Tinted Broad Spectrum SPF 30 Shade 3

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Version

v4

Effective date

October 1, 2025

Original packager

Yes

Sections captured

9

Identifiers

Document ID
401d358d-a725-ef20-e063-6294a90a2f0c
Set ID
07503a1f-d530-e3bb-e063-6294a90a8ae3
Application numbers
M020
Product NDCs
82870-008
Package NDCs
82870-008-01
Original packager NDCs
—

Names & Manufacturers

Brand names
Wonderscreen Tinted Broad Spectrum SPF 30 Shade 3
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

Acitve 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 month: Ask a doctor
Inactive Ingredient (1)

Sequence 1

Inactive Ingredients: Water, Ethylhexyl Olivate, Dimethicone, C9-12 Alkane, Cocoglycerides, Caprylic/Capric Triglyceride, Hydroxyethyl Dimethicone Laurate, Pentylene Glycol, Iron Oxides (CI 77492), Butyloctyl Salicylate, Glycerin, Jojoba Esters, Pyrus Malus (Apple) Fruit Extract, Polymethylsilsesquioxane, Diheptyl Succinate, Disteardimonium Hectorite, Squalane, Phenoxyethanol, Sodium Chloride, Iron Oxides (CI 77499), Polyhydroxystearic Acid, Trihydroxystearin, Iron Oxides (CI 77491), Triethyl Citrate, Hydroxyacetophenone, Persea Gratissima (Avocado) Oil, Dipotassium Glycyrrhizate, Fructooligosaccharides, Sodium Citrate, Beta Vulgaris (Beet) Root Extract, Hydrogenated Vegetable Oil, Tetrasodium Glutamate Diacetate, Sodium Dehydroacetate, Capryloyl Glycerin/Sebacic acid Copolymer, Glycine Soja (Soybean) Seed Extract, Tocopherol
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 Wonderscreen SPF 30 Shade 3
Purpose (1)

Sequence 1

Uses: Helps prevent sunburn
Spl Product Data Elements (1)

Sequence 1

Wonderscreen Tinted Broad Spectrum SPF 30 Shade 3 Zinc Oxide PENTYLENE GLYCOL TETRASODIUM GLUTAMATE DIACETATE COCO-GLYCERIDES CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) DISTEARDIMONIUM HECTORITE TRIHYDROXYSTEARIN APPLE DIHEPTYL SUCCINATE HYDROXYACETOPHENONE FERRIC OXIDE RED SODIUM DEHYDROACETATE TOCOPHEROL POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) SQUALANE PHENOXYETHANOL MEDIUM-CHAIN TRIGLYCERIDES FERRIC OXIDE YELLOW BUTYLOCTYL SALICYLATE GLYCERIN JOJOBA OIL, RANDOMIZED GLYCYRRHIZINATE DIPOTASSIUM FERROSOFERRIC OXIDE SODIUM CHLORIDE POLYHYDROXYSTEARIC ACID (2300 MW) TRIETHYL CITRATE AVOCADO OIL SODIUM CITRATE BEET WATER ZINC OXIDE ZINC OXIDE C9-12 ALKANE DIMETHICONE ETHYLHEXYL OLIVATE
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 Shade 3'],
 'generic_name': ['ZINC OXIDE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Dime Beauty Co, LLC'],
 'package_ndc': ['82870-008-01'],
 'product_ndc': ['82870-008'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['401d358d-a725-ef20-e063-6294a90a2f0c'],
 'spl_set_id': ['07503a1f-d530-e3bb-e063-6294a90a8ae3'],
 'substance_name': ['ZINC OXIDE'],
 'unii': ['SOI2LOH54Z']}