Label: ATTITUDE SUNLY MINERAL SUNSCREEN STICK TROPICAL SPF 30- zinc oxide stick
- NDC Code(s): 61649-091-60
- 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.
- 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.
- Children under 6 months of age: Ask a doctor.
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Vitis Vinifera (Grape) Seed Oil, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Polyhydroxystearic Acid, Helianthus Annuus (Sunflower) Seed Wax, Behenyl Behenate, Ricinus Communis (Castor) Seed Oil, Mica, Coco-Caprylate/Caprate, Butyrospermum Parkii (Shea) Butter, Glyceryl Behenate, Euphorbia Cerifera (Candelilla) Wax, Capryloyl Glycerin/Sebacic Acid Copolymer, Silica, Gamma-Octalactone*, Anisaldehyde*, Cis-3-Hexenyl Salicylate*, Methyldihydrojasmonate*, Triethyl Citrate*, *fragrance (Parfum).
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ATTITUDE SUNLY MINERAL SUNSCREEN STICK TROPICAL SPF 30
zinc oxide stickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61649-091 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 g Inactive Ingredients Ingredient Name Strength COCONUT OIL (UNII: Q9L0O73W7L) GRAPE SEED OIL (UNII: 930MLC8XGG) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K) METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y) CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T) CANDELILLA WAX (UNII: WL0328HX19) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) SHEA BUTTER (UNII: K49155WL9Y) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) P-ANISALDEHYDE (UNII: 9PA5V6656V) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) BEHENYL BEHENATE (UNII: K8NU647RJ0) MICA (UNII: V8A1AW0880) 3-HEXENYL SALICYLATE, CIS- (UNII: C78Y9OR6YH) CASTOR OIL (UNII: D5340Y2I9G) SUNFLOWER OIL (UNII: 3W1JG795YI) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61649-091-60 60 g in 1 CARTON; 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(61649-091) , label(61649-091) , manufacture(61649-091) , pack(61649-091)