OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active Ingredients
Zinc Oxide 19.5%
Drug Facts
Active Ingredients
Zinc Oxide 19.5%
Purpose
Sunscreen
Uses
measures (see Directions), decreases the risk
of skin cancer and early aging caused
by the sun.
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.
Keep out of reach of children.
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 Information
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.
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
50 mL Bottle
15 mL Carton
15 mL Bottle
res
| Class | Version | Type | Effective |
|---|---|---|---|
| ZINC CATION Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f47a510b-6679-4664-b2d6-47b5c4afe7cc | Product name | 4 | 20260217 |
| 7b19f89e-0a13-4d4e-a994-a46d39d008b9 | Product name | 1 | 20251120 |
| 030ce964-9b2d-45aa-b5d3-f78ce03ef61c | Product name | 2 | 20250515 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 0306390c-dd77-4363-afe0-63c58088b2a1 | Product name | 1 | 20220120 |
| 503ea967-4b9c-48cf-9e87-c7975295849d | Product name | 2 | 20220120 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 190f2a5b-bbc8-65c7-fcb0-97891307b917 | Product name | 1 | 20140508 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54111-190-01 | 111 SKIN SUNSCREEN SPF 50 | 50 mL in 1 BOTTLE, PUMP | SOLUTION | 50 | 2 | |
| 54111-190-01 | 111 SKIN SUNSCREEN SPF 50 | 1 in 1 CARTON | SOLUTION | 1 | 2 | |
| 54111-190-02 | 111 SKIN SUNSCREEN SPF 50 | 15 mL in 1 BOTTLE, PUMP | SOLUTION | 15 | 2 | |
| 54111-190-02 | 111 SKIN SUNSCREEN SPF 50 | 1 in 1 CARTON | SOLUTION | 1 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 54111-190 | 54111-190-01, 54111-190-02 |
Every source-derived ingredient row is available through these pages.
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 111 SKIN SUNSCREEN SPF 50 | ZINC OXIDE | Bentley Laboratories, LLC | b1265797-71dd-4302-ab26-dbff6ccec856 | 2026-01-23 | Warnings | 54111-190-01 54111-190-02 54111-190 54111019001 54111019002 3885e519-7eb8-4b06-97fe-85471b0e6951 b1265797-71dd-4302-ab26-dbff6ccec856 |
Adverse event summaries are temporarily unavailable. Other product information remains available.