Label: SURFERS BARRIER SPF 50- zinc oxide, titanium dioxide stick
- NDC Code(s): 58518-021-01
- Packager: Avasol LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated April 11, 2023
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- Active Ingredients
- Purpose
- Uses
- Warnings
- Directions
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Inactive ingredients
*Cocos Nucifera (Coconut) Oil, *Simmondsia Chinensis (Jojoba) Seed Oil, *Helianthus annuus (Sunflower) Oil, **Euphorbia Cerifera (Candelilla) wax *Calophyllum Inophyllum (Tamanu) Oil, *Argania spinosa (Argan) Oil, Silica, **Theobroma Grandiflorum (Cupuacu) Butter, **Mauritia Flexuosa (Buriti) Fruit Oil, *Butyrospermum Parkii (Shea Butter), Rubus idaeus (Raspberry) Seed Oil, *Beeswax, Tocopherol(Vitamin E), Iron oxides, Vanilla Planifolia (Vanilla) Fruit Extract, *Propolis, Plankton Extract, Mica, **Leptospermum scoparium (Manuka) Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract, *Cinnamomum Zeylanicum(Cinnamon) Bark Oil. **Organic **Wildcrafted
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INGREDIENTS AND APPEARANCE
SURFERS BARRIER SPF 50
zinc oxide, titanium dioxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58518-021 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 COCONUT OIL (UNII: Q9L0O73W7L) JOJOBA OIL (UNII: 724GKU717M) SUNFLOWER OIL (UNII: 3W1JG795YI) CANDELILLA WAX (UNII: WL0328HX19) TAMANU OIL (UNII: JT3LVK84A1) ARGAN OIL (UNII: 4V59G5UW9X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) THEOBROMA GRANDIFLORUM SEED (UNII: Q7RNT1G37V) SHEANUT (UNII: 84H6HBP32L) MAURITIA FLEXUOSA WHOLE (UNII: 83ULF8L5FI) RUBUS IDAEUS SEED (UNII: M3CL7US2ZG) YELLOW WAX (UNII: 2ZA36H0S2V) PROPOLIS WAX (UNII: 6Y8XYV2NOF) TOCOPHEROL (UNII: R0ZB2556P8) MICA (UNII: V8A1AW0880) VANILLA BEAN (UNII: Q74T35078H) HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472) MANUKA OIL (UNII: M6QU9ZUH2X) ROSEMARY (UNII: IJ67X351P9) CINNAMON BARK OIL (UNII: XE54U569EC) FERROUS OXIDE (UNII: G7036X8B5H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58518-021-01 28 g in 1 TUBE; Type 0: Not a Combination Product 01/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 01/02/2020 Labeler - Avasol LLC (078822898) Establishment Name Address ID/FEI Business Operations Avasol LLC 078822898 MANUFACTURE(58518-021)