Label: ATTITUDE MINERAL SUNSCREEN TROPICAL SPF 30- zinc oxide cream
- NDC Code(s): 61649-021-15
- Packager: 9055-7588 Quebec Inc. DBA Attitude
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 24, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active or medicinal ingredient
- Purpose
- Use
- Warnings
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Directions
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.
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Inactive or non-medicinal ingredients
Aqua / Water / Eau, Caprylic/Capric Triglyceride, Cetearyl Glucoside, Glyceryl Stearate, Cetearyl Alcohol, Polyhydroxystearic Acid, C10-18 Triglycerides, Glycerin, Ethylhexylglycerin, Caprylyl Glycol, Behenyl Alcohol, Sodium Chloride, Xanthan Gum, Sodium Gluconate, Gamma-Octalactone*, Anisaldehyde*, Cis-3-Hexenyl Salicylate*, Methyldihydrojasmonate*, Triethyl Citrate*, *fragrance (Parfum).
- Other Information
- QUESTIONS
- PRINCIPAL DISPLAY PANEL - 150 g Tube Label
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INGREDIENTS AND APPEARANCE
ATTITUDE MINERAL SUNSCREEN TROPICAL SPF 30
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61649-021 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 MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI) DOCOSANOL (UNII: 9G1OE216XY) SODIUM CHLORIDE (UNII: 451W47IQ8X) XANTHAN GUM (UNII: TTV12P4NEE) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SODIUM GLUCONATE (UNII: R6Q3791S76) 3-HEXENYL SALICYLATE, CIS- (UNII: C78Y9OR6YH) METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y) P-ANISALDEHYDE (UNII: 9PA5V6656V) .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61649-021-15 150 g in 1 TUBE; Type 0: Not a Combination Product 11/24/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 11/24/2023 Labeler - 9055-7588 Quebec Inc. DBA Attitude (201137051) Establishment Name Address ID/FEI Business Operations 9055-7588 Quebec Inc. DBA Attitude 204307099 manufacture(61649-021) , label(61649-021) , pack(61649-021) , analysis(61649-021)
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