Label: DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30- titanium dioxide and zinc oxide lotion
- NDC Code(s): 57677-063-01
- Packager: Aveda Corporation
- 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 May 23, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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
-
Directions
- shake well. apply generously 15 minutes before sun exposure
- for sunscreen use, 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 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-sleeve shirts, pants, hats, and sunglasses
- children under 6 months of age: ask a doctor
-
Inactive ingredients
Water\Aqua\Eau, Dimethicone, Dicaprylyl Carbonate, Butyloctyl Salicylate, Coco-Caprylate/Caprate, Propanediol, Dipentaerythrityl Tri-Polyhydroxystearate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Aleurites Moluccana (Kukui) Seed Oil, Trimethylsiloxysilicate, Silica, Hydrogenated Castor Oil/Sebacic Acid Copolymer, Rosmarinus Officinalis (Rosemary) Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Caffeine, Punica Granatum (Pomegranate) Extract, Polygonum Cuspidatum, Root Extract, Zingiber Officinale (Ginger) Root Extract, Vanilla Planifolia Fruit Extract, Oryzanol, Ascorbyl Palmitate, Hydroxyapatite, Dimethicone Silylate, Triethoxycaprylylsilane, Dimethicone Crosspolymer-3, Dimethicone/Polyglycerin-3 Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Caprylyl Glycol, Phenoxyethanol <ILN41846>
- Other Information
- PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton
-
INGREDIENTS AND APPEARANCE
DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30
titanium dioxide and zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57677-063 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 63 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 41 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H) PROPANEDIOL (UNII: 5965N8W85T) DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52) KUKUI NUT OIL (UNII: TP11QR7B8R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) ROSEMARY (UNII: IJ67X351P9) SUNFLOWER OIL (UNII: 3W1JG795YI) TOCOPHEROL (UNII: R0ZB2556P8) CAFFEINE (UNII: 3G6A5W338E) POMEGRANATE (UNII: 56687D1Z4D) REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7) GINGER (UNII: C5529G5JPQ) VANILLA BEAN (UNII: Q74T35078H) ORYZANOL (UNII: SST9XCL51M) ASCORBYL PALMITATE (UNII: QN83US2B0N) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57677-063-01 1 in 1 CARTON 05/01/2016 1 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 05/01/2016 Labeler - Aveda Corporation (071352058) Registrant - Estee Lauder Companies Inc. (790802086) Establishment Name Address ID/FEI Business Operations The Estee Lauder Inc 802599436 manufacture(57677-063) , pack(57677-063) , label(57677-063)
