Label: SPF 30 SPORT SUNSCREEN- zinc oxide lotion
- NDC Code(s): 55165-0204-1
- Packager: Juice Beauty
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 January 5, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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
- Due to the nature of mineral formulations, separation may occur. Shake tube before use. Moisturize daily by applying generously and evenly 15 minutes before sun exposure.
- May be used over moisturizer or alone.
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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 10 a.m.–2 p.m. wear long-sleeved
- shirts, pants, hats, and sunglasses
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Reapply:
- after 80 minutes of swimming or sweating immediately
- after towel drying
- at least every 2 hours
- Children under 6 months: Ask a doctor.
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Inactive Ingredients
Aloe barbadensis (organic aloe juice)1, cocos nucifera (organic coconut oil)1, pyrus malus (organic apple juice)1, vitis vinifera (organic white grape juice)1, caprylic/capric triglyceride2, sorbitan stearate, ricinus communis (castor seed oil), hydrogenated methyl abietate, polyglyceryl-10 laurate2, magnesium sulfate, helianthus annuus (organic sunflower seed oil)1, simmondsia chinensis (organic jojoba seed oil)1, tocopherol (Vitamin E), magnesium ascorbyl phosphate (Vitamin C), citrus limon (lemon extract), iron oxides, phenethyl alcohol, ethylhexylglycerin2, citrus reticulata (mandarin oil), citrus aurantium (petitgrain oil).
- Other Information
- Questions?
- PRINCIPAL DISPLAY PANEL - 90 mL Tube Label
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INGREDIENTS AND APPEARANCE
SPF 30 SPORT SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55165-0204 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 apple juice (UNII: 9871T0PD5P) WINE GRAPE (UNII: 3GOV20705G) ALOE VERA LEAF (UNII: ZY81Z83H0X) coconut oil (UNII: Q9L0O73W7L) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) CASTOR OIL (UNII: D5340Y2I9G) polyglyceryl-10 laurate (UNII: MPJ2Q8WI8G) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) jojoba oil (UNII: 724GKU717M) tocopherol (UNII: R0ZB2556P8) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) Hydrogenated Methyl Abietate (UNII: A23O709X8O) LEMON (UNII: 24RS0A988O) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) ethylhexylglycerin (UNII: 147D247K3P) mandarin oil (UNII: NJO720F72R) CITRUS AURANTIUM LEAFY TWIG OIL (UNII: 5K6H1IMT3D) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55165-0204-1 90 mL in 1 TUBE; Type 0: Not a Combination Product 06/03/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 06/03/2014 Labeler - Juice Beauty (263151582)
