Label: BRICKELL ELEMENT DEFENSE MOISTURIZER SPF-45- octocrylene, octisalate, zinc oxide cream
- NDC Code(s): 82247-234-00
- Packager: BRICKELL BRANDS LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 11, 2023
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- Drug Facts
- Active Ingredients
- Uses:
- Warnings:
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Directions:
- Apply liberally 15 minutes before sun exposure.
- Children under 6 months of age: ask a doctor.
- Reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every2 hourr
- Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection SPF of 15 or higher, along with other sun protection measues including: SUN PROTECTION MEASURES:
- Limit time in the sun, especially between 10 am - 2 pm.
- Wear long-sleeve shirts, pants, hats and sunglasses.
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Inactive Ingredients:
Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citrullus Lantatus (Watermelon) Extract, Decyl Glucoside, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, polyacrylamide, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate.
- Other Information:
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
BRICKELL ELEMENT DEFENSE MOISTURIZER SPF-45
octocrylene, octisalate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82247-234 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 100 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) WATERMELON (UNII: 231473QB6R) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) SUNFLOWER OIL (UNII: 3W1JG795YI) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82247-234-00 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 09/21/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 09/21/2021 Labeler - BRICKELL BRANDS LLC (081141606)
