Label: PRO FORMULA- zinc oxide, titanium dioxide stick
- NDC Code(s): 58518-030-03, 58518-030-04
- Packager: Avasol LLC
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated April 24, 2023
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
*Caprylic/Capric Triglyceride (Coconut), *Cocos Nucifera (Coconut) Oil,*Helianthus annuus (Sunflower) Oil, **Euphorbia cerifera (Candelilla) wax, *Calophyllum Inophyllum (Tamanu)Oil,*Beeswax,**Theobroma Grandiflorum (Cupuacu) Seed Butter, Mica, Tocopherol (Vitamin E),*Aloe Vera Leaf, Iron oxides, *Propolis, *Rosmarinus Officinalis (Rosemary) Leaf Extract, **Leptospermum scoparium (Manuka) Oil,*Cinnamomum Zeylanicum(Cinnamon) Bark Oil.
*Organic **Wildcrafted
- Other information
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- Principal Display Panel - 28 g Tube Label
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INGREDIENTS AND APPEARANCE
PRO FORMULA
zinc oxide, titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58518-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 24.5 g in 100 g TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 6 g in 100 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) COCONUT OIL (UNII: Q9L0O73W7L) SUNFLOWER OIL (UNII: 3W1JG795YI) YELLOW WAX (UNII: 2ZA36H0S2V) TAMANU OIL (UNII: JT3LVK84A1) CANDELILLA WAX (UNII: WL0328HX19) THEOBROMA GRANDIFLORUM SEED (UNII: Q7RNT1G37V) MICA (UNII: V8A1AW0880) TOCOPHEROL (UNII: R0ZB2556P8) FERROUS OXIDE (UNII: G7036X8B5H) PROPOLIS WAX (UNII: 6Y8XYV2NOF) ALOE VERA LEAF (UNII: ZY81Z83H0X) MANUKA OIL (UNII: M6QU9ZUH2X) ROSEMARY (UNII: IJ67X351P9) CINNAMON BARK OIL (UNII: XE54U569EC) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58518-030-03 28 g in 1 TUBE; Type 0: Not a Combination Product 05/01/2023 2 NDC:58518-030-04 224 g in 1 POUCH; Type 0: Not a Combination Product 05/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/01/2023 Labeler - Avasol LLC (078822898) Establishment Name Address ID/FEI Business Operations Avasol LLC 078822898 MANUFACTURE(58518-030)