Label: ELEVEN PERFECT FORM TINTED LIP BALM GAME DAY- zinc oxide cream
- NDC Code(s): 71644-012-10
- Packager: Cyberderm Laboratories inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated October 26, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
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INACTIVE INGREDIENT
Inactive ingredients
Caprylic/capric triglyceride, Butyrospermum Parkii (Shea) Butter, Myrica Cerifera (Bayberry) Fruit Wax, Vegetable Oil, Hydrogenated Vegetable Oil, Euphorbia Cerifera (Candelilla) Wax, Lauryl Laurate, Polyhydroxystearic Acid, Behenyl Behenate, Polyglyceryl-10 Stearate, Sodium Stearoyl Lactylate, Glyceryl Isostearate, Tocopherol. May contain Red 7, Aluminum Hydroxide, BetaVulgaris (Beet) Root Extract, Citric Acid, Ascorbic Acid, Maltodextrin, Monoammonium Glycyrrhizinate
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STORAGE AND HANDLING
Other information
- Protect this product from excessive heat and direct sun
- May stain some fabrics.
- 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
- Children under 6 months of age: ask a doctor
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ELEVEN PERFECT FORM TINTED LIP BALM GAME DAY
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71644-012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 20 g in 100 mL Inactive Ingredients Ingredient Name Strength AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) BEET (UNII: N487KM8COK) D&C RED NO. 7 (UNII: ECW0LZ41X8) ASCORBIC ACID (UNII: PQ6CK8PD0R) MALTODEXTRIN (UNII: 7CVR7L4A2D) .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SHEA BUTTER (UNII: K49155WL9Y) MORELLA CERIFERA FRUIT WAX (UNII: L41B20QT0M) SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN) CANDELILLA WAX (UNII: WL0328HX19) LAURYL LAURATE (UNII: GPW77G0937) BEHENYL BEHENATE (UNII: K8NU647RJ0) POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91) CORN OIL (UNII: 8470G57WFM) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71644-012-10 1 in 1 CARTON 06/19/2020 1 10 mL 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 06/18/2020 Labeler - Cyberderm Laboratories inc. (242524267)