Label: ELTAMD UV RESTORE- titanium dioxide, zinc oxide sunscreen lotion
- NDC Code(s): 72043-2630-1, 72043-2630-2, 72043-2630-4, 72043-2630-5
- Packager: CP Skin Health Group, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 9, 2023
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- Warnings
- Active Ingredients
- Uses
- Uses
- Keep out of reach of children
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Directions
Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen if swimming or sweating. Reapply 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
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Inactive Ingredients
water, coco-caprylate/caprate, butyloctyl salicylate, octyldodecyl neopentanoate, caprylic/capric triglyceride, methyl glucose sesquistearate, silica, glyceryl stearate, PEG-100 stearate, PEG-20 methyl glycose sesquisterate, phenoxyethanol, triethoxycaprylylsilane, polyhydroxystearic acid, glycerin, saccharide isomerate, glyceryl behenate, xanthan gum, zingiber officiale (ginger) root extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalene, ethylhexylglycerin, tocopheryl acetate, sclerotium gum, lecithin, pulluan, dimethicone, polysorbate 60, ethylene/methacrylate copolymer, mica
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- Labeling
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INGREDIENTS AND APPEARANCE
ELTAMD UV RESTORE
titanium dioxide, zinc oxide sunscreen lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72043-2630 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 20 g in 1000 g ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 150 g in 1000 g Inactive Ingredients Ingredient Name Strength PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) WATER (UNII: 059QF0KO0R) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PEG-100 STEARATE (UNII: YD01N1999R) METHYL GLUCOSE SESQUISTEARATE (UNII: V1YW10H14D) PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U) GLYCERIN (UNII: PDC6A3C0OX) SACCHARIDE ISOMERATE (UNII: W8K377W98I) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) SQUALANE (UNII: GW89575KF9) POLYSORBATE 60 (UNII: CAL22UVI4M) XANTHAN GUM (UNII: TTV12P4NEE) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PULLULAN (UNII: 8ZQ0AYU1TT) BETASIZOFIRAN (UNII: 2X51AD1X3T) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) DIMETHICONE (UNII: 92RU3N3Y1O) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE (UNII: 1Q73Q2JULR) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) MICA (UNII: V8A1AW0880) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) GINGER (UNII: C5529G5JPQ) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72043-2630-4 2 g in 1 PACKET; Type 0: Not a Combination Product 10/01/2020 2 NDC:72043-2630-2 57 g in 1 TUBE; Type 0: Not a Combination Product 10/01/2020 3 NDC:72043-2630-5 14 g in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2020 4 NDC:72043-2630-1 48 g in 1 BOTTLE; Type 0: Not a Combination Product 11/09/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 10/01/2020 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(72043-2630)