111 SKIN SUNSCREEN SPF 50

Manufacturer
Bentley Laboratories, LLC
Effective date
2026-01-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:34:41

Label at a glance#

Product111 SKIN SUNSCREEN SPF 50
Active ingredientZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active Ingredients

Zinc Oxide 19.5%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

Uses

  • Helps prevent sunburn
  • If used as directed with other sun protection

measures (see Directions), decreases the risk

of skin cancer and early aging caused

by the sun.

WARNINGS SECTION

Warnings

Do not use on damaged or broken skin.

For external use only.

When using this product keep out of eyes.

If product gets into the eyes, rinse with water to remove

Stop use and consult a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions
• Apply generously and evenly to face and
neck 15-20 minutes before sun exposure.
• Reapply at least every 2 hours
• Use a water-resistant sunscreen when
swimming or sweating. • Sun Protection
Measures. Spending time in the sun increases
your risk of skin cancer and early aging.
To reduce this risk, regularly use a sunscreen
with a Broad Spectrum SPF value of 15 or higher
and other sun protection measures including:
   - Limiting time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor.

OTHER SAFETY INFORMATION

Other Information

  • Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENT SECTION

Inactive ingredients/Ingredients inactifs
Isododecane, Water (Aqua/Eau), Coco-Caprylate/
Caprate, Caprylyl Methicone, Propanediol,
Glycerin, Polyglyceryl-4 Diisostearate/
Polyhydroxystearate/Sebacate, Cetyl PEG/
PPG-10/1 Dimethicone, Methyl Dihydroabietate,
Tapioca Starch, Argania Spinosa Kernel Oil,
Sodium Chloride, Tocopheryl Acetate,
Dimethicone, Ethyl Ferulate, Disteardimonium
Hectorite, Glycine Soja (Soybean) Oil,
Hydroxyacetophenone, Isopentyldiol, Zinc
Stearate, Propylene Carbonate, Physales
Pubescens Fruit Juice, 1,2-Hexanediol, Caprylyl
Glycol, Caprylic/Capric Triglyceride, Sodium
Gluconate, Polyglyceryl-3 Diisostearate,
Bisabolol, Escin, Fragrance (Parfum),
Hydroxypropyl Cyclodextrin, Morus Alba Root
Extract, Oryza Sativa (Rice) Extract, Oryza Sativa
(Rice) Germ Extract, Tetrahexyldecyl Ascorbate,
Polyglutamic Acid, Polyglyceryl-6 Laurate,
Polycglyceryl-10 Oleate, Trifolium Pratense
(Clover) Flower Extract Sorbitan Palmitate,
Acetyl Cysteine, Soy Isoflavones,
Glycosphingolipids, Tetramethyl
Acetyloctahydronaphthalenes, Geranyl Acetate,
Terpineol, Dimethyl Phenethyl Acetate.

Product Labeling:  111 SKIN SUNSCREEN SPF 50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

111SKIN

HARLEY ST. LONDON

SPF 50

DR YANNIS ALEXANDRIDES

SUNSCREEN

SPF50

℮50mL./1.69 Fl.Oz.

Made in the USA for:

111 SKIN LTD

111 Harley Street, London,

WiG 6AW, UK

www.111skin@111skin.com

50 mL Carton

50mL 111 Skin Box50mL 111 Skin Box

50 mL Bottle

50mL 111 Skin Botl50mL 111 Skin Botl

15 mL Carton

15mL 111 Skin Box15mL 111 Skin Box

15 mL Bottle

15mL 111 Skin Botl15mL 111 Skin Botl

res

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
7b19f89e-0a13-4d4e-a994-a46d39d008b9Product name120251120
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-190-01111 SKIN SUNSCREEN SPF 5050 mL in 1 BOTTLE, PUMPSOLUTION502
54111-190-01111 SKIN SUNSCREEN SPF 501 in 1 CARTONSOLUTION12
54111-190-02111 SKIN SUNSCREEN SPF 5015 mL in 1 BOTTLE, PUMPSOLUTION152
54111-190-02111 SKIN SUNSCREEN SPF 501 in 1 CARTONSOLUTION12

Products#

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

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54111-19054111-190-01, 54111-190-02

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 47 matching rows.

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
111 SKIN SUNSCREEN SPF 50ZINC OXIDEBentley Laboratories, LLCb1265797-71dd-4302-ab26-dbff6ccec8562026-01-23WarningsExact identifier
ndc (package): 54111-190-01
ndc (package): 54111-190-02
ndc (product): 54111-190
ndc11 (package): 54111019001
ndc11 (package): 54111019002
spl id: 3885e519-7eb8-4b06-97fe-85471b0e6951
spl set id: b1265797-71dd-4302-ab26-dbff6ccec856

Reported adverse events (FAERS/openFDA)#

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