Hydro Essence Broad Spectrum Sunscreen Spf 40 Cream
FDA Label NDC 72957-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Private Label Skin Care for the product Hydro Essence Broad Spectrum Sunscreen Spf 40 (NDC 72957-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Zinc Oxide 10%
Octinoxate 7.5%
Purpose
Sunscreen
Uses
• 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.
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
Otc - 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.
Directions
• Apply liberally on a clean dry face, avoiding delicate eye area 15 minutes before sun exposure • reapply: • after 80 minutes of swimming • or sweating. • immediately after towel dryings • 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 value of 15 or higher and other sun protection measures including: • limit 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
Other Information
• protect the product in this container from excessive heat and direct sun
Inactive Ingredients
Water/Aqua/Eau, Oleth-3 Phosphate, Cyclopentasiloxane, Isopropyl Palmitate, Hydrogenated Soybean Oil, Caprylic/Capric Triglyceride, Glycerin, Dimethicone, Plankton Extract, Apple (Pyrus Malus) Fruit Extract, Hydroxyethyl, Oleth-10, Knot Grass (Polygonum Aviculare) Extract, Sodium Hyaluronate, Tocopheryl Acetate, Ethylhexylglycerin, Lecithin, Hydrogenated Soy Polyglycerides, Xanthan Gum, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylyl Glycol, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, PEG/PPG-450/50 Trimethylolpropane Lauryl Ether, PEG-7 Trimethylolpropane Coconut Ether, Disodium EDTA, Polyisobutene, Triethoxycaprylylsilane, 1,2 Hexanediol, C15-23 Alkane, Phenoxyethanol
Packaging
Hydro Essence (72957 008 01)
* Please review the disclaimer below.
