Label: ATTITUDE SUNLY LIP BALM UNSCENTED SPF 15- zinc oxide stick
- NDC Code(s): 61649-093-01
- Packager: 9055-7588 Quebec Inc. DBA Attitude
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 15, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Adults and children older than 6 months.
- Apply generously 15 minutes before sun exposure.
- Reapply at least every 2 hours, after eating or drinking.
- Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm; and wear long-sleeved shirts, pants, hats and sunglasses.
- Use a water resistant sunscreen if swimming or sweating.
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Cocos Nucifera (Coconut) Oil, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Ricinus Communis (Castor) Seed Oil, Argania Spinosa (Argan) Kernel Oil, Glyceryl Behenate, Euphorbia Cerifera (Candelilla) Wax, Octyldodecanol, CI 77491 (Iron Oxides), CI 77492 (Iron Oxides), CI 77742 (Manganese Violet), CI 77499 (Iron Oxides), Jojoba Esters, Trihydroxystearin, Stearoyl Glutamic Acid.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ATTITUDE SUNLY LIP BALM UNSCENTED SPF 15
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61649-093 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 10 g in 100 g Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SHEA BUTTER (UNII: K49155WL9Y) BEHENYL BEHENATE (UNII: K8NU647RJ0) SUNFLOWER OIL (UNII: 3W1JG795YI) TRIHYDROXYSTEARIN (UNII: 06YD7896S3) STEAROYL GLUTAMIC ACID (UNII: 4R4O71786G) FERRIC OXIDE RED (UNII: 1K09F3G675) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ARGAN OIL (UNII: 4V59G5UW9X) CASTOR OIL (UNII: D5340Y2I9G) CANDELILLA WAX (UNII: WL0328HX19) OCTYLDODECANOL (UNII: 461N1O614Y) MANGANESE VIOLET (UNII: 72M48QQV8Q) COCONUT OIL (UNII: Q9L0O73W7L) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) FERROSOFERRIC OXIDE (UNII: XM0M87F357) JOJOBA OIL (UNII: 724GKU717M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61649-093-01 8.5 g in 1 TUBE; Type 0: Not a Combination Product 02/15/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 02/15/2024 Labeler - 9055-7588 Quebec Inc. DBA Attitude (201137051) Establishment Name Address ID/FEI Business Operations 9055-7588 Quebec Inc. DBA Attitude 204307099 analysis(61649-093) , label(61649-093) , manufacture(61649-093) , pack(61649-093)
