Label: ALLSWELL MINERAL SUNSCREEN SPF 30- zinc oxide lotion
- NDC Code(s): 69555-043-01
- Packager: Stream2Sea, 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 4, 2023
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- Active ingredient
- Purpose
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Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures ( See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
- Warnings
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Directions
- Apply liberally 15 minutes before sun exposure, reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every two hours
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Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad-spectrum SPF value of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10am – 2pm
- wear long-sleeve shirts, pants, hats and sunglasses
- Children under 6 months: Ask a doctor
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Inactive Ingredients
Helianthus Annus (Sunflower) Seed Oil, Persea Gratissima (Avocado) Oil, Caprylic Capric Triglycerides, Butyrospermum Parkii (Shea) Butter, Beeswax, Helianthus Annus (Sunflower) Seed Wax, Polyhydroxystearic Acid, Glyceryl Caprylate (and) Glyceryl Undecylenate, Non-GMO Corn Starch, Acrylates Copolymer, Vitamin E
- Other Information
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALLSWELL MINERAL SUNSCREEN SPF 30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69555-043 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 22 g Inactive Ingredients Ingredient Name Strength SUNFLOWER OIL (UNII: 3W1JG795YI) AVOCADO OIL (UNII: 6VNO72PFC1) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SHEA BUTTER (UNII: K49155WL9Y) YELLOW WAX (UNII: 2ZA36H0S2V) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) STARCH, CORN (UNII: O8232NY3SJ) BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69555-043-01 51 in 1 TUBE; Type 0: Not a Combination Product 03/28/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 03/28/2023 Labeler - Stream2Sea, LLC (052920828) Establishment Name Address ID/FEI Business Operations Stream2Sea, LLC 052920828 manufacture(69555-043)
