Label: COTZ LIP BALM- titanium dioxide, zinc oxide stick
- NDC Code(s): 58892-124-45
- Packager: Fallien Cosmeceuticals, LTD
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 25, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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.
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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
- 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 10:00 a.m.-2:00 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
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Inactive Ingredients:
Alumina, Aluminum Hydroxide, Aluminum Stearate, Asorbic Acid, Ascorbyl Palmitate, C 12- 15Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil
- Other Information:
- KEEP OUT OF REACH OF CHILDREN
- Principal Display Panel - 4.5 g Carton Label
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INGREDIENTS AND APPEARANCE
COTZ LIP BALM
titanium dioxide, zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 40 mg in 1 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 55 mg in 1 g Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM STEARATE (UNII: U6XF9NP8HM) ASCORBIC ACID (UNII: PQ6CK8PD0R) ASCORBYL PALMITATE (UNII: QN83US2B0N) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CETEARYL ISONONANOATE (UNII: P5O01U99NI) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) DIPROPYLENE GLYCOL CAPRYLATE (UNII: CJ981S4H3T) ETHYLHEXYL PALMITATE (UNII: 2865993309) CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB) KIWI FRUIT OIL (UNII: 66086CWP3Q) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) HEXYLDECANOL (UNII: 151Z7P1317) HEXYL LAURATE (UNII: 4CG9F9W01Q) FERRIC OXIDE RED (UNII: 1K09F3G675) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) CERESIN (UNII: Q1LS2UJO3A) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) STEARIC ACID (UNII: 4ELV7Z65AP) TOCOPHEROL (UNII: R0ZB2556P8) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GINGER OIL (UNII: SAS9Z1SVUK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58892-124-45 1 in 1 CARTON 05/01/2021 1 4.5 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 04/15/2019 Labeler - Fallien Cosmeceuticals, LTD (958388357) Establishment Name Address ID/FEI Business Operations Custom Analytics LLC 144949372 analysis(58892-124) Establishment Name Address ID/FEI Business Operations Fragrance Manufacturing Inc. (FMI) 793406000 manufacture(58892-124) , pack(58892-124)
