Label: SPF 30 OIL-FREE MOISTURIZER- zinc oxide lotion
- NDC Code(s): 55165-0202-1
- 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 4, 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 shake and knead the 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
- Reapply at least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Children under 6 months: Ask a doctor.
Après avoir nettoyé le visage le matin, appliquer sur peau humide.
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Inactive Ingredients
Aloe barbadensis leaf juice1, caprylic/capric triglyceride2, pyrus malus (apple) juice1, vitis vinifera (white grape) juice1, sorbitan stearate2, polyglyceryl-10 laurate2, magnesium sulfate, tocopherol2 (Vitamin E), magnesium ascorbyl phosphate (Vitamin C), sodium hyaluronate2, punica granatum (pomegranate) juice extract1, algae extract, cucumis sativus extract (cucumber) extract, panthenol, citrus medica limonum (lemon) fruit extract, iron oxides, ethylhexylglycerin2, citrus reticulata (mandarin) oil, citrus aurantium (petitgrain) oil.
- Other Information
- Questions?
- PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton
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INGREDIENTS AND APPEARANCE
SPF 30 OIL-FREE MOISTURIZER
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55165-0202 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) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) polyglyceryl-10 laurate (UNII: MPJ2Q8WI8G) MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) tocopherol (UNII: R0ZB2556P8) HYALURONATE SODIUM (UNII: YSE9PPT4TH) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) POMEGRANATE JUICE (UNII: 99S671U9KB) CUCUMBER JUICE (UNII: 61845009SP) PANTHENOL (UNII: WV9CM0O67Z) LEMON (UNII: 24RS0A988O) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) 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:55165-0202-1 60 mL in 1 TUBE; Type 0: Not a Combination Product 05/15/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 05/15/2010 Labeler - Juice Beauty (263151582)
