FDA.reportPublic FDA data

NexGen Sunscreen Broad Spectrum SPF 36

Manufacturer
Cosmetic Enterprises Ltd.
Effective date
2023-10-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:23:48

Label at a glance#

ProductNexGen Sunscreen Broad Spectrum SPF 36 Doc Martins
Active ingredientOCTINOXATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

​Active Ingredients:                           Purpose:

Octinoxate 7.0% Benzophenone-3    ​Sunscreen

(Oxybenzone) 5.0% Octocrylene 4.0% Avobenzone 3.0%

OTC - PURPOSE SECTION

​Uses:

Helps prevent sunburn. If used as described with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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 immediately

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs.

WARNINGS SECTION

​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.

DOSAGE & ADMINISTRATION SECTION

​Directions:

- Apply liberally 15 minutes before sun exposure.

- Reapply after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

- Children under 6 months: ask a doctor.

INACTIVE INGREDIENT SECTION

Beeswax, Caprylic/Capric Triglyceride, Cetyl Alcohol, Cetyl Dimethicone, Cetyl Lactate, Cpernicia Cerifera (Carnauba) Wax, C10-30 Cholesterol/Lanosterol, Euphorbia Cerifera (Candelilla) Wax, Fragrance, Neopentyl Glycol Diheptanoate, Phenoxyethanol, Polybutene, Propylene Carbonate, Propylene Glycol Dibenzoate, Sea Whip Extract, Silica, Stearalkonium Hectorite

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Doc Martin's of Maui

NexGen Sunscreen

New Skin Bonding Technology

Broad Spectrum SPF 36

Water Resistant (80 minutes)

2.0 FL OZ (60 mL)

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56152-501056152-5010-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETYL ALCOHOL936JST6JCNIACT
CETYL LACTATEA7EVH2RK4OIACT
CARNAUBA WAXR12CBM0EIZIACT
C10-30 CHOLESTEROL/LANOSTEROL ESTERS137SL7IL0YIACT
CANDELILLA WAXWL0328HX19IACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
PROPYLENE CARBONATE8D08K3S51EIACT
PROPYLENE GLYCOL DIBENZOATEEQY32Z1AN4IACT
PSEUDOPTEROGORGIA ELISABETHAEUDY3H1OUX5IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STEARALKONIUM HECTORITEOLX698AH5PIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
OCTOCRYLENE5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB

Source Document#

Source XML · Source PDF

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
26d33f4f-278a-d219-e063-6394a90a4beff4987940-ee36-4bbd-b018-5dbf3a9688f42024-11-13WarningsExact identifier
spl set id: f4987940-ee36-4bbd-b018-5dbf3a9688f4

Reported adverse events (FAERS/openFDA)#

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