FDA.reportPublic FDA data

DRMTLGY

Manufacturer
Drmtlgy, LLC
Effective date
2026-04-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:55:40

Label at a glance#

ProductBroad Spectrum SPF45
Active ingredientZINC OXIDE, OCTINOXATE
Label structure9 sections

Indications and 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.

Dosage and administration

• Apply generously to face and neck, avoiding eye area. Wait at least 30 minutes before sun exposure.  • Reapply 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 value of SPF 15 or higher and other sun protection measures including: • limit time in the sun, especi...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12.00%

Octinoxate 7.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• 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

WARNINGS SECTION

• 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 SECTION

• Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Apply generously to face and neck, avoiding eye area. Wait at least 30 minutes before sun exposure. 
• Reapply 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 value of SPF 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Cyclopentasiloxane, Niacinamide, Oleth-3 Phosphate, Octyldodecyl Neopentanoate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glycerin, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Tocopheryl Acetate, Knot Grass (Polygonum Aviculare) Extract, Sodium Hyaluronate, Disodium EDTA, Sodium Hydroxide, Citric Acid, Phenoxyethanol, Ethylhexylglycerin, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Triethoxycaprylylsilane

Questions or comments? 

OTC - QUESTIONS SECTION

1-888-DRMTLGY

SPL UNCLASSIFIED SECTION

​SmrtSun™

Hydrating hybrid sun protection with hyaluronic acid

Broad Spectrum
UVA/UVB Protection

Made in U.S.A. with globally sourced materials
Dist. by DRMTLGY LLC
Los Angeles, CA 91304 | DRMTLGY.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BroadSpectrumSPF45BroadSpectrumSPF45

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83286-014-01Broad Spectrum SPF4550 mL in 1 BOTTLEGEL502

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83286-01483286-014-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
OCTINOXATE4Y5P7MUD51ACTIB
WATER059QF0KO0RIACT
CYCLOMETHICONE 50THT5PCI0RIACT
NIACINAMIDE25X51I8RD4IACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
GLYCERINPDC6A3C0OXIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
PEG-7 TRIMETHYLOLPROPANE COCONUT ETHERMVJ3AD73GGIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
HYALURONATE SODIUMYSE9PPT4THIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM HYDROXIDE55X04QC32IIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S)RLA2U05Z4QIACT
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONEX75PL53TZJIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Broad Spectrum SPF45ZINC OXIDE, OCTINOXATEDrmtlgy, LLC0445ee5f-45a8-4fd5-ae4d-62f66e6f0be82026-04-21WarningsExact identifier
ndc (package): 83286-014-01
ndc (product): 83286-014
ndc11 (package): 83286001401
spl id: 4f1a74ff-5ef6-4174-bb9b-b3ade1dc4f9c
spl set id: 0445ee5f-45a8-4fd5-ae4d-62f66e6f0be8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.