Label: DERM INSTITUTE DAILY DEFENSE PROTECTION SUNSCREEN BROAD SPECTRUM SPF50- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 81521-001-01 - Packager: Beautcella Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 February 8, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
- Warnings
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Directions
- Use in the a.m. after serum and before foundation or makeup
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water-resistant sunscreen if swimming or sweating
- children under 6 months of age: Ask a doctor
- 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
- Other information
- Questions?
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Inactive ingredients
Water (Aqua), Isononyl Isononanoate, Butylene Glycol, Caprylic/Capric Triglyceride, Cetyl Ethylhexanoate, Propanediol, Sodium Chloride, Diethylhexyl Carmonate, Stearic Acid, Alumina, Disteardimonium Hectorite, Polyhydroxystearic Acid, Iron Oxides (CI 77492), Phenoxyethanol, Bacopa Monnieri Extract, Lavandula Angustifolia (Lavender) Oil, Polyglyceryl-6 Polyricinoleate, Glycerin, Butyrospermum Parkii (Shea) Butter, Acetyl Tyrosine, Tocopheryl Acetate, Urea, Allantoin, o-Cymen-5-ol, Iron Oxides (CI 77491), Proline, Ethylhexylglycerin, Iron Oxides (CI 77499), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Hydrolyzed Vegetable Protein, Adenosine Triphosphate, Hydroxyethylcellulose, Xanthophylls, PEG-12 Glyceryl Laurate, Rosmarinus Officininalis (Rosemary) Leaf Oil, PEG-35 Castor Oil, PVP, Lecithin, Alteromonas Ferment Extract, Magnesium Ascorbyl Phosphate, Silybum Marianum Extract, Potassium Sorbate, Caprylyl Glycol, Disodium EDTA, Tocopherol, Xanthan Gum, Ergothioneine, Chondrus Crispus Extract
- Company Information
- Product Packaging
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INGREDIENTS AND APPEARANCE
DERM INSTITUTE DAILY DEFENSE PROTECTION SUNSCREEN BROAD SPECTRUM SPF50
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81521-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 88.5 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 19.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM CHLORIDE (UNII: 451W47IQ8X) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CETYL ETHYLHEXANOATE (UNII: 134647WMX4) WATER (UNII: 059QF0KO0R) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) O-CYMEN-5-OL (UNII: H41B6Q1I9L) FERRIC OXIDE RED (UNII: 1K09F3G675) FERROSOFERRIC OXIDE (UNII: XM0M87F357) LUTEIN (UNII: X72A60C9MT) ROSEMARY OIL (UNII: 8LGU7VM393) BACOPA MONNIERI WHOLE (UNII: DUB5K84ELI) SHEA BUTTER (UNII: K49155WL9Y) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALLANTOIN (UNII: 344S277G0Z) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PROPANEDIOL (UNII: 5965N8W85T) ALUMINUM OXIDE (UNII: LMI26O6933) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) EDETATE DISODIUM (UNII: 7FLD91C86K) POVIDONE (UNII: FZ989GH94E) ERGOTHIONEINE (UNII: BDZ3DQM98W) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) LAVENDER OIL (UNII: ZBP1YXW0H8) POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR) GLYCERIN (UNII: PDC6A3C0OX) PEG-12 GLYCERYL LAURATE (UNII: J07WW42G15) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) MILK THISTLE (UNII: U946SH95EE) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TOCOPHEROL (UNII: R0ZB2556P8) PROLINE (UNII: 9DLQ4CIU6V) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) TEA TREE OIL (UNII: VIF565UC2G) ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE) HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) XANTHAN GUM (UNII: TTV12P4NEE) PHENOXYETHANOL (UNII: HIE492ZZ3T) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ACETYL L-TYROSINE (UNII: DA8G610ZO5) UREA (UNII: 8W8T17847W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81521-001-01 1 in 1 CARTON 05/01/2021 1 25 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/01/2021 Labeler - Beautcella Inc. (928453625)
