WONDERSCREEN TINTED BROAD SPECTRUM SPF 30- zinc oxide cream

Wonderscreen Tinted Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Wonderscreen Tinted Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Dime Beauty Co, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Zinc Oxide 19.0%

Purpose: Sunscreen

PURPOSE

Uses:

• Helps prevent sunburn. Higher SPF gives more sunburn protection.

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.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

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

PRINCIPAL DISPLAY PANEL

Dime

Wonderscreen

Tinted Broad Spectrum SPF 30

50 G

INGREDIENTS AND APPEARANCE

WONDERSCREEN TINTED BROAD SPECTRUM SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82870-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	19 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SOYBEAN (UNII: L7HT8F1ZOD)
APPLE (UNII: B423VGH5S9)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
BEET (UNII: N487KM8COK)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
SQUALANE (UNII: GW89575KF9)
DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
JOJOBA OIL (UNII: 724GKU717M)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
COCO-GLYCERIDES (UNII: ISE9I7DNUG)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82870-005-01	50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/02/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/02/2023

Labeler - Dime Beauty Co, LLC (058459261)