111 SKIN SUNSCREEN SPF 50- zinc oxide solution

111 SKIN SUNSCREEN SPF 50 by

Drug Labeling and Warnings

111 SKIN SUNSCREEN SPF 50 by is a Otc medication manufactured, distributed, or labeled by Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

Active Ingredients

Zinc Oxide 19.5%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

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

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

Keep out of reach of children.

DOSAGE & ADMINISTRATION

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

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

DR YANNIS ALEXANDRIDES

SUNSCREEN

SPF50

50mL./1.69 Fl.Oz.

Made in the USA for /

111SKIN LTD

111 Harley Street, London,

WiG 6AW, UK

www.111skin@111skin.com

Box

Bottle

res

INGREDIENTS AND APPEARANCE

111 SKIN SUNSCREEN SPF 50 
zinc oxide solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54111-190
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	19.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
CAPRYLYL METHICONE (UNII: Q95M2P1KJL)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
TAPIOCA STARCH (UNII: 24SC3U704I)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYL FERULATE (UNII: 5B8915UELW)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GLYCINE SOJA (SOYBEAN) OIL UNSAPONIFIABLES (UNII: WZ7DY7GBV6)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
ZINC STEARATE (UNII: H92E6QA4FV)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PHYSALIS PUBESCENS FRUIT JUICE (UNII: GM2TDN9DZI)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
SODIUM GLUCONATE (UNII: R6Q3791S76)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
BISABOLOL (UNII: 24WE03BX2T)
ESCIN (UNII: RUU8G67GQM)
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)
MORUS ALBA ROOT (UNII: CST1G9BZGD)
RICE GERM (UNII: 7N2B70SFEZ)
RICE GERM OIL (UNII: D4H5GGS5JF)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
POLYGLUTAMIC ACID (1200 MW) (UNII: MGE3733FR2)
POLYGLYCERYL-6 LAURATE (UNII: Q48X4BL3TV)
POLYGLYCERYL-10 OLEATE (UNII: 55C81W76DH)
TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828)
SORBITAN PALMITATE (UNII: 77K6Z421KU)
ACETYL CYSTEINE (UNII: WYQ7N0BPYC)
SOY ISOFLAVONES (UNII: 71B37NR06D)
HYDROXYETHYL PALMITYL OXYHYDROXYPROPYL PALMITAMIDE (UNII: ISA73Z2140)
TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES (UNII: 2JU6ZH6GRE)
GERANYL ACETATE (UNII: 3W81YG7P9R)
TERPINEOL (UNII: R53Q4ZWC99)
DIMETHYL BENZYL CARBINYL ACETATE (UNII: 6Y9488RL8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54111-190-01	1 in 1 CARTON	05/23/2025
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/23/2025

Labeler - Bentley Laboratories, LLC (068351753)

Registrant - Bentley Laboratories, LLC (068351753)