Label: DAILY DEFENCE SUNSCREEN BROAD SPECTRUM SPF30- octinoxate, octisalate, avobenzone, and octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 63712-123-01 - Packager: ZELENS Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated November 6, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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Directions
- apply liberally 15 minutes before sun exposure
- reapply:
- after 40 minutes of swimming or sweating
- immediately after towel drying
- 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 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- children under 6 months: Ask a doctor
- Other information
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Inactive ingredients
Water, Cyclohexasiloxane, Glycerin, Butylene Glycol, Butyloctyl Salicylate, Isononyl Isononanoate, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Micrococcus Lysate, Perilla Frutescens Leaf Extract, Sodium Hylauronate, Glutamylamidoethyl Imidazole, Ascorbyl Tetraisopalmitate, Tocopheryl Acetate, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Echinacea Angustifolia Leaf Extract, Ginkgo Biloba Leaf Extract, Pinus Strobus Bark Extract, Lecithin, Silica, Hydrogenated Palm Glycerides, Cyclopentasiloxane, PVP, Potassium Cetyl Phosphate, Sorbitol, Ceteareth-20, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Polyacrylate, Fragrance, Linalool, Sorbic Acid, Chlorphenesin, Phenoxyethanol, BHT, Sodium Hydroxide, Disodium EDTA
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Box
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INGREDIENTS AND APPEARANCE
DAILY DEFENCE SUNSCREEN BROAD SPECTRUM SPF30
octinoxate, octisalate, avobenzone, and octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63712-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 74 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 27 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 6 (UNII: XHK3U310BA) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) DIMETHICONE (UNII: 92RU3N3Y1O) PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68) HYALURONATE SODIUM (UNII: YSE9PPT4TH) ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CENTELLA ASIATICA (UNII: 7M867G6T1U) ECHINACEA ANGUSTIFOLIA LEAF (UNII: FS7G8S6PJ8) GINKGO (UNII: 19FUJ2C58T) PINUS STROBUS BARK (UNII: 8PJ4761097) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) SORBITOL (UNII: 506T60A25R) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) LINALOOL, (+/-)- (UNII: D81QY6I88E) SORBIC ACID (UNII: X045WJ989B) CHLORPHENESIN (UNII: I670DAL4SZ) PHENOXYETHANOL (UNII: HIE492ZZ3T) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETATE DISODIUM (UNII: 7FLD91C86K) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63712-123-01 1 in 1 BOX 06/02/2014 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 06/02/2014 Labeler - ZELENS Limited (217149018) Establishment Name Address ID/FEI Business Operations Originitalia 441072253 manufacture(63712-123)
