Label: ELTAMD UV AOX MIST- zinc oxide sunscreen spray
- NDC Code(s): 72043-2671-5
- Packager: CP Skin Health Group, Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 9, 2023
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- Warnings
- Active Ingredient
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- Uses
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Directions
Apply liberally 15 minutes before sun exposure. Hold container 4-6 inches from the skin to apply. Do not spray product directly into face, spray on hands then apply to face. do not apply in windy conditions. Use in a well-ventilated area and avoide inhallation. Reapply after 40 mintues 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.
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Inactive Ingredients
water, octyldodecyl neopentanoate, C15-19 alkane, butyloctyl salicylate, coco-caprylate/caprate, polyhydroxystearic acid, cetearyl alcohol, phenoxyethanol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, triethoxycaprylylsilane, coco-glucoside, aloe barbadensis leaf juice, tocopheryl acetate, isohexadecane, scloerolium gum, glycerin, cocos nucifer (coconut) fruit extract, ethylhexylglycerin, tetrahexyldecyl ascorbate, polysorbate 60, sorbitan isostearate
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INGREDIENTS AND APPEARANCE
ELTAMD UV AOX MIST
zinc oxide sunscreen sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72043-2671 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 14.0 g in 1000 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) COCOS NUCIFERA WHOLE (UNII: 245J88W96L) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) ISOHEXADECANE (UNII: 918X1OUF1E) POLYSORBATE 60 (UNII: CAL22UVI4M) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) C15-19 ALKANE (UNII: CI87N1IM01) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) COCO GLUCOSIDE (UNII: ICS790225B) BETASIZOFIRAN (UNII: 2X51AD1X3T) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72043-2671-5 1 in 1 CARTON 03/31/2023 1 141 g in 1 CAN; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/31/2023 Labeler - CP Skin Health Group, Inc (611921669) Registrant - Swiss-American CDMO, LLC (080170933) Establishment Name Address ID/FEI Business Operations Swiss-American CDMO, LLC 080170933 manufacture(72043-2671)
