Label: PREMIUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 72113-101-01 - Packager: Eden Brands
- 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 February 12, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
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
- Children under 6 months of age: ask a doctor
- Sun Protection Measures: Spending time in the sun increases your risk of 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 your time in the sun, especially from 10a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
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INACTIVE INGREDIENT
Inactive ingredients:
Caprylic/Capric Triglyceride, Vitis Vinifera (grape) Seed Extract, Butyrospermum Parkii (shea) Butter, Silica, Aluminum Starch Octenylsuccinate, Euphorbia Cerifera (Candelilla) Wax/Candelilla Cera, Beeswax/Cera Alba, Glyceryl Isostearate, Brassica Campestris/Aleurites Fordii Oil Copolymer, Polyhydroxystearic Acid, Simmondsia Chinensis (jojoba) Seed Oil, Tocopherol, Carthamus Tinctorious (Safflower) Seed Oil, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Water/Aqua, Camelilla sinensis leaf Extract, Rosa Canina Fruit Oil.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREMIUM MINERAL SUNSCREEN BROAD SPECTRUM SPF 30
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72113-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 22 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) WHITE WAX (UNII: 7G1J5DA97F) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CUCUMBER (UNII: YY7C30VXJT) GREEN TEA LEAF (UNII: W2ZU1RY8B0) SAFFLOWER OIL (UNII: 65UEH262IS) SHEA BUTTER (UNII: K49155WL9Y) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) VITIS VINIFERA SEED (UNII: C34U15ICXA) GLYCERIN (UNII: PDC6A3C0OX) ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) CANDELILLA WAX (UNII: WL0328HX19) JOJOBA OIL (UNII: 724GKU717M) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72113-101-01 85 g in 1 BOX; Type 0: Not a Combination Product 02/12/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 02/12/2018 Labeler - Eden Brands (081062339) Establishment Name Address ID/FEI Business Operations Baxter Laboratories Pty. Ltd. 740537709 manufacture(72113-101)
