Label: ELTAMD SKINCARE UV AOX ELEMENTS SPF50 TINTED- titanium dioxide, zinc oxide sunscreen lotion
- NDC Code(s): 72043-2519-1, 72043-2519-2
- Packager: CP Skin Health Group, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 14, 2023
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- Official Label (Printer Friendly)
- Warnings
- Uses
- Purpose
- Active Ingredients
- Keep out of reach of children
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Directions
Apply liberally 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours. 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.
- Other information:
- QUESTIONS
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Inactive ingredients
Water, Dimethicone, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, cetyl dimethicone, dimethicone PEG-10/15 crosspolymer,Polyhydroxystearic Acid, alumina, phenoxyethanol, iron oxides, Triethoxycaprylylsilane, sodium chloride, hydrogen dimethicone, sodium hyaluronate, potassium sorbate, Tocopheryl Acetate, tocopherol, bisabolol, carnosine, dipropylene glycol, ascorbyl palmitate, soidum citrate, canola oil, zingiber officinale (giner) root extract
- Labeling
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INGREDIENTS AND APPEARANCE
ELTAMD SKINCARE UV AOX ELEMENTS SPF50 TINTED
titanium dioxide, zinc oxide sunscreen lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72043-2519 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 44 g in 1000 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 135 g in 1000 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB) DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) PHENOXYETHANOL (UNII: HIE492ZZ3T) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) SODIUM CHLORIDE (UNII: 451W47IQ8X) HYDROGEN DIMETHICONE (30 CST) (UNII: JF2ZJ6R2WD) HYALURONIC ACID (UNII: S270N0TRQY) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TOCOPHEROL (UNII: R0ZB2556P8) CARNOSINE (UNII: 8HO6PVN24W) DIPROPYLENE GLYCOL (UNII: E107L85C40) ASCORBYL PALMITATE (UNII: QN83US2B0N) SODIUM CITRATE (UNII: 1Q73Q2JULR) CANOLA OIL (UNII: 331KBJ17RK) ZINGIBER OFFICINALE WHOLE (UNII: IN6Q3S3414) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) ALUMINUM OXIDE (UNII: LMI26O6933) Product Characteristics Color brown Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72043-2519-1 48 g in 1 TUBE; Type 0: Not a Combination Product 11/14/2023 2 NDC:72043-2519-2 2 g in 1 PACKET; Type 0: Not a Combination Product 11/14/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 11/14/2023 Labeler - CP Skin Health Group, Inc (611921669) Registrant - CP Skin Health Group, Inc (611921669) Establishment Name Address ID/FEI Business Operations Swiss-American CDMO, LLC 080170933 manufacture(72043-2519)
