WONDERSCREEN BROAD SPECTRUM SPF 30- zinc oxide cream 
Wasatch Product Development, LLC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Wonderscreen Broad Spectrum SPF 30

Active Ingredient: Zinc Oxide

Purpose: Sunscreen

Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs.

Warning:

Directions:

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, Squalane, Dipotassium Glycyrrhizate, Beta Vulgaris (Beet) Root Extract, Fructooligosaccharides, Glycine Soja (Soybean) Seed Extract Diheptyl Succinate, Disteardimonium Hectorite, Phenoxyethanol, Sodium Chloride, Polyhydroxystearic Acid, Trihydroxystearin, Triethyl Citrate, Hydroxyacetophenone, Sodium Citrate, Tetrasodium Glutamate Diacetate, Sodium Dehydroacetate, Capryloyl Glycerin/Sebacic Acid Copolymer

DIME

Wonderscreen

Broad Spectrum SPF 30

50 G

Wonderscreen SPF 30 Box

Pump bottle

WONDERSCREEN BROAD SPECTRUM SPF 30 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44717-062
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE19 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
DIMETHICONE 100 (UNII: RO266O364U)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
SQUALANE (UNII: GW89575KF9)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
BEET (UNII: N487KM8COK)  
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
GLYCERIN (UNII: PDC6A3C0OX)  
APPLE (UNII: B423VGH5S9)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44717-062-0150 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/25/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02002/25/2022
Labeler - Wasatch Product Development, LLC. (962452533)

Revised: 9/2022
Document Id: e895d590-80ad-cc41-e053-2a95a90a7c04
Set id: e895d942-e50e-1ad6-e053-2995a90a0e02
Version: 1
Effective Time: 20220913
 
Wasatch Product Development, LLC.