111 Skin Sunscreen Spf 50

111 Skin Sunscreen Spf 50
SPL v2
SPL
SPL Set ID b1265797-71dd-4302-ab26-dbff6ccec856
Route
TOPICAL
Published
Effective Date 2026-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (19.5 g)
Inactive Ingredients
Isododecane Water Coco-caprylate/caprate Caprylyl Methicone Propanediol Glycerin Polyglyceryl-4 Diisostearate/polyhydroxystearate/sebacate Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Methyl Dihydroabietate Tapioca Starch Argania Spinosa Kernel Oil Sodium Chloride .alpha.-tocopherol Acetate Dimethicone Ethyl Ferulate Disteardimonium Hectorite Glycine Soja (soybean) Oil Unsaponifiables Hydroxyacetophenone Isopentyldiol Zinc Stearate Propylene Carbonate Physalis Pubescens Fruit Juice 1,2-hexanediol Caprylyl Glycol Caprylic/capric Triglyceride Sodium Gluconate Polyglyceryl-3 Diisostearate Bisabolol Escin Hydroxypropyl Betadex Morus Alba Root Rice Germ Rice Germ Oil Tetrahexyldecyl Ascorbate Polyglutamic Acid (1200 Mw) Polyglyceryl-6 Laurate Polyglyceryl-10 Oleate Trifolium Pratense Flower Sorbitan Palmitate Acetyl Cysteine Soy Isoflavones Hydroxyethyl Palmityl Oxyhydroxypropyl Palmitamide Tetramethyl Acetyloctahydronaphthalenes Geranyl Acetate Terpineol Dimethyl Benzyl Carbinyl Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-23

Description

Drug Facts Active Ingredients Zinc Oxide 19.5%


Medication Information

Warnings and Precautions

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.

Indications and 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.

Dosage and 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.

Description

Drug Facts Active Ingredients Zinc Oxide 19.5%

Section 50565-1

Keep out of reach of children.

Section 51727-6

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.

Section 55105-1

Purpose

Sunscreen

Section 55106-9

Drug Facts

Active Ingredients

Zinc Oxide 19.5%

Section 60561-8

Other Information

  • Protect this product from excessive heat and direct sun.

Product Labeling:  111 Skin Sunscreen Spf 50

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

[email protected]

50 mL Carton

50 mL Bottle

15 mL Carton

15 mL Bottle

res


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

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.

Section 55105-1 (55105-1)

Purpose

Sunscreen

Section 55106-9 (55106-9)

Drug Facts

Active Ingredients

Zinc Oxide 19.5%

Section 60561-8 (60561-8)

Other Information

  • Protect this product from excessive heat and direct sun.

Product Labeling:  111 Skin Sunscreen Spf 50 (Product Labeling:  111 SKIN SUNSCREEN SPF 50)

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

[email protected]

50 mL Carton

50 mL Bottle

15 mL Carton

15 mL Bottle

res


Advanced Ingredient Data


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