Label: VACATION MINERAL BROAD SPECTRUM SPF 30 SUNSCREEN- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 80641-002-01 - Packager: Vacation Inc.
- 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 May 5, 2021
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- 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 2 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months of age: ask a physician.
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Inactive ingredients
Allantoin, Aloe Barbadensis (Aloe Vera) Leaf Extract, Butyrospermum Parkii (Shea) Butter, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Caprylate/Caprate, Caprylyl Glyceryl Ether, Cucumis Sativus (Cucumber) Fruit Extract, Dicaprylyl Carbonate, Diheptyl Succinate, Galactoarabinan, Glycerin, Helianthus Annuus (Sunflower) Extract, Magnesium Sulfate, Methyl Dihydroabietate, Niacinamide (Vitamin B3), Oryza Sativa (Rice) Bran Extract, Polyglyceryl-2 Oleate, Polyglyceryl-2 Stearate, Polyhydroxystearic Acid, Propanediol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol (Vitamin E), Triethoxycaprylylsilane, Water
- Other information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 100 ML Tube Label
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INGREDIENTS AND APPEARANCE
VACATION MINERAL BROAD SPECTRUM SPF 30 SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80641-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 20 g in 100 mL Inactive Ingredients Ingredient Name Strength Allantoin (UNII: 344S277G0Z) Aloe Vera Leaf (UNII: ZY81Z83H0X) Shea Butter (UNII: K49155WL9Y) Caprylhydroxamic Acid (UNII: UPY805K99W) Medium-Chain Triglycerides (UNII: C9H2L21V7U) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) Caprylyl Caprylate/Caprate (UNII: 22MCG4RSMR) Caprylyl Glyceryl Ether (UNII: MI97BW74XZ) Cucumber (UNII: YY7C30VXJT) Dicaprylyl Carbonate (UNII: 609A3V1SUA) Diheptyl Succinate (UNII: 057N7SS26Y) Galactoarabinan (UNII: SL4SX1O487) Glycerin (UNII: PDC6A3C0OX) Helianthus Annuus Flowering Top (UNII: BKJ0J3D1BP) Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB) Methyl Dihydroabietate (UNII: 7666FJ0J9F) NIACIN (UNII: 2679MF687A) Rice Bran (UNII: R60QEP13IC) Polyglyceryl-2 Oleate (UNII: 5759J47SAM) Polyglyceryl-2 Stearate (UNII: 253MC0P0YV) Propanediol (UNII: 5965N8W85T) Rosemary (UNII: IJ67X351P9) .Alpha.-Tocopherol (UNII: H4N855PNZ1) Triethoxycaprylylsilane (UNII: LDC331P08E) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80641-002-01 100 mL in 1 TUBE; Type 0: Not a Combination Product 05/19/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/19/2021 Labeler - Vacation Inc. (117644631)
