Otc - Active Ingredient
Drug Facts
Active Ingredients
Zinc Oxide 19.5%
111 Skin Sunscreen Spf 50 Solution
FDA Label NDC 54111-190
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bentley Laboratories, Llc for the product 111 Skin Sunscreen Spf 50 (NDC 54111-190). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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.
Otc - 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
Box
Bottle
res
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