Drug labels

Helios Hydration TITANIUM DIOXIDE,ZINC OXIDE OCTYLDODECYL NEOPENTANOATE POLYEST…

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Set ID
0983af62-d939-e9cd-e063-6394a90a4c8c
ID
0fb9f44f-372f-b9d4-e063-6294a90a0d96
Effective time
20240124
Version
2
SPL product data elements

Helios Hydration TITANIUM DIOXIDE,ZINC OXIDE OCTYLDODECYL NEOPENTANOATE POLYESTER-7 CETYL ALCOHOL PEG-75 STEARATE ALKYL (C12-15) BENZOATE TRICETEARETH-4 PHOSPHATE CETETH-20 SODIUM ASCORBATE ETHYLHEXYL ISONONANOATE GLYCERIN BETASIZOFIRAN DIMETHICONOL TRIETHOXYCAPRYLYLSILANE TETRAETHYL SILICATE CROSSPOLYMER (4000000 MW) PHENOXYETHANOL DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) SILICON DIOXIDE SQUALANE HYDROGENATED SOYBEAN LECITHIN TOCOPHEROL BUTYLOCTYL SALICYLATE NEOPENTYL GLYCOL DIHEPTANOATE GLYCERYL STEARATE SE HYALURONATE SODIUM ALLANTOIN CAPRYLYL GLYCOL PULLULAN ETHYLHEXYLGLYCERIN TRILAURETH-4 PHOSPHATE EDETATE DISODIUM ANHYDROUS DICRATERIA ROTUNDA OIL RUTTNERA LAMELLOSA OIL POTASSIUM SORBATE HEXYLENE GLYCOL OAT GREEN TEA LEAF LEVOMENOL APPLE LYSOPHOSPHATIDYLCHOLINE, SOYBEAN XANTHAN GUM STEARETH-20 TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE

Package label principal display panel

Outer packaging Outer Packaging apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating 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 value of 15 or higher and other sun protection measures including: limit your time in the sun, especially from 10 a.m. – 2 p.m. wear long‐sleeved shirts, pants, hats, and sunglasses children under 6 months of age: Ask a doctor Titanium Dioxide 2.00% w/w, Zinc Oxide 1.00% w/w Sunscreen Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun Water, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Ethylhexyl Isononanoate, Glycerin, Polyester-7, Neopentyl Glycol Diheptanoate, Cetyl Alcohol, Glyceryl Stearate, Squalane, PEG-75 Stearate, Phenoxyethanol, Bisabolol, Hydrolyzed Sodium Hyaluronate, Pyrus Malus (Apple) Fruit Extract, C12-15 Alkyl Benzoate, Lysolecithin, Sclerotium Gum, Dimethiconol/Caprylylsilsesquioxane/Silicate Crosspolymer, Allantoin, Caprylyl Glycol, Triceteareth-4 Phosphate, Pullulan, Xanthan Gum, Ceteth-20, Steareth-20, Ethylhexylglycerin, Hexylene Glycol, Trilaureth-4 Phosphate, Sodium Hyaluronate, Disodium EDTA, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer, Lecithin, Silica, Dicrateria Rotunda Oil, Ruttnera Lamellosa Oil, Avena Sativa (Oat) Kernel Extract, Camellia Sinensis Leaf Extract, Potassium Sorbate, Sodium Ascorbate, Tocopherol 877-203-2404 protect the product in this container from excessive heat and direct sun

Dosage and administration

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating 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 value of 15 or higher and other sun protection measures including: limit your time in the sun, especially from 10 a.m. – 2 p.m. wear long‐sleeved shirts, pants, hats, and sunglasses children under 6 months of age: Ask a doctor

Active ingredient
Titanium Dioxide 2.00% w/w, Zinc Oxide 1.00% w/w
Purpose
Sunscreen Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Keep out of reach of children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Warnings

For external use only Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Indications and usage

helps prevent sunburn if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Inactive ingredient

Water, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Ethylhexyl Isononanoate, Glycerin, Polyester-7, Neopentyl Glycol Diheptanoate, Cetyl Alcohol, Glyceryl Stearate, Squalane, PEG-75 Stearate, Phenoxyethanol, Bisabolol, Hydrolyzed Sodium Hyaluronate, Pyrus Malus (Apple) Fruit Extract, C12-15 Alkyl Benzoate, Lysolecithin, Sclerotium Gum, Dimethiconol/Caprylylsilsesquioxane/Silicate Crosspolymer, Allantoin, Caprylyl Glycol, Triceteareth-4 Phosphate, Pullulan, Xanthan Gum, Ceteth-20, Steareth-20, Ethylhexylglycerin, Hexylene Glycol, Trilaureth-4 Phosphate, Sodium Hyaluronate, Disodium EDTA, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer, Lecithin, Silica, Dicrateria Rotunda Oil, Ruttnera Lamellosa Oil, Avena Sativa (Oat) Kernel Extract, Camellia Sinensis Leaf Extract, Potassium Sorbate, Sodium Ascorbate, Tocopherol

Questions
877-203-2404
Other safety information
protect the product in this container from excessive heat and direct sun
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.