the tinted serum broad spectrum spf 50+

the tinted serum broad spectrum spf 50+
SPL v5
SPL
SPL Set ID f8ffcbc0-0dd3-4fce-b38b-37d38d631b61
Route
topical
Published
Effective Date 2022-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc cation (240 mg)
Inactive Ingredients
trisiloxane isoamyl laurate alkyl (c12-15) benzoate butyloctyl salicylate cyclomethicone 5 ethylhexyl methoxycrylene water tricontanyl povidone argan oil .alpha.-tocopherol acetate pentaerythrityl tetraisostearate propanediol isostearic acid glyceryl caprylate titanium dioxide boron nitride 1,2-hexanediol mica disteardimonium hectorite glycerin sodium chloride ferric oxide yellow levomenol propylene carbonate green tea leaf caprylhydroxamic acid limonene, (+)- citrus bergamia leaf oil orange oil, cold pressed juniperus deppeana wood oil geranium oil, algerian type 7-dehydrocholesterol citrus aurantium flower oil clove leaf oil maltodextrin silicon dioxide ferric oxide red anigozanthos flavidus flowering top syzygium luehmannii fruit stannic oxide aspalathus linearis leaf butylene glycol sodium lactate sodium pyrrolidone carboxylate ferrosoferric oxide pentylene glycol ceteareth-25 linalool, (+/-)- dimethicone magnesium aspartate zinc gluconate cetyl alcohol .beta.-citronellol, (r)- hyaluronate sodium davidsonia pruriens fruit sodium benzoate glycine ethylhexylglycerin potassium sorbate behenic acid ceramide np cholesterol copper gluconate phenylalanine dipivefrin hydrochloride threonine valine isoleucine histidine fructose inositol lactic acid niacinamide urea phenoxyethanol citric acid monohydrate ceramide ng serine glutamic acid ceramide ap 3-dehydroxy ceramide 1 aspartic acid leucine caprooyl phytosphingosine n-hexanoylsphingosine alanine lysine arginine tyrosine

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2022-11-25 Until 2026-09-01
Purpose

Sunscreen

Description

Zinc Oxide 24%

Medication Information

Warnings

For external use only. 

Uses
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures ( see Directions ), decreases the risk of skin cancer and early skin ageing caused by the sun.
Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply 
  • At least every 2 hours 
  • Use a water resistant sunscreen if swimming or sweating.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: 
  • Limit time in the sun, especially from 10 a.m -2p.m.
  • Wear long sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months of age: Ask a doctor. 
Other Information
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

Trisiloxane, Isoamyl Laurate, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cyclopentasiloxane, PEG-10 Dimethicone, Ethylhexyl Methoxycrylene, Lauryl PEG-10 Tris (Trimethylsiloxy) silylethyl Dimethicone, Aqua (Water), Styrene/Acrylates Copolymer, Triacontanyl PVP, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Pentaerhthrityl Tetraisostearate, Methyl Methacrylate Crosspolymer, Propanediol, Isostearic Acid, Glyceryl Caprylate, CI 77891 (Titanium Dioxide), Polyhydroxystearic Acid, Boron Nitride, 1,2-Hexanediol, Mica, Disteardimonium Hectorite, Glycerin, Sodium Chloride, CI 77492 (Iron Oxides), Bisabolol, Propylene Carbonate, Camellia Sinensis Leaf Extract, Hydrolyzed Keratin, Caprylhydroxamic Acid, Sodium Potassium Aluminum Silicate, Limonene, Citrus Aurantium Bergamia (Bergamot) Leaf Oil, Citrus Aurantium Dulcis (Orange) Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Oil, 7-Dehydrocholesterol, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Maltodextrin, Silica, CI 77491 (Iron Oxides), Anigozanthos Flavidus Flower Extract, Syzygium Luehmannii Fruit Extract, Tin Oxide, Aspalathus Linearis Leaf Extract, Butylene Glycol, Sodium Lactate, Sodium PCA, Melanin, CI 77499 (Iron Oxides), Pentylene Glycol, Ceteareth-25, Linalool, Dimethicone, Magnesium Aspartate, Zinc Gluconate, Cetyl Alcohol, Citronellol, Sodium Hyaluronate, Davidsonia Pruriens Fruit Extract, Sodium Benzoate, Glycine, Ethylhexylglycerin, Potassium Sorbate, Behenic Acid, Ceramide NP, Cholesterol, Copper Gluconate, Fructose, Inositol, Lactic Acid, Niacinamide, Urea, Phenoxyethanol, Citric Acid, Ceramide NS, Serine, Glutamic Acid, Ceramide AP, Ceramide EOP, Ceramide EOS, Asparic Acid, Leucine, Acetyl Tetrapeptide-22, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Propine, Threonine, Valine, Isoleucine, Histidine

Description

Zinc Oxide 24%

Do Not Use
  • On damaged or broken skin.
Drug Facts

Active Ingredient

Zinc Oxide 24%

Package Labeling:

Package Labeling:3ml

Package Labeling:5ml

When Using This Product
  • Keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If
  • Rash occurs.
Keep Out of Reach of Children.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings

For external use only. 

Uses
  • Helps prevent sunburn.
  • If used as directed with other sun protection measures ( see Directions ), decreases the risk of skin cancer and early skin ageing caused by the sun.
Purpose

Sunscreen

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Reapply 
  • At least every 2 hours 
  • Use a water resistant sunscreen if swimming or sweating.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: 
  • Limit time in the sun, especially from 10 a.m -2p.m.
  • Wear long sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months of age: Ask a doctor. 
Other Information
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients (Inactive ingredients)

Trisiloxane, Isoamyl Laurate, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cyclopentasiloxane, PEG-10 Dimethicone, Ethylhexyl Methoxycrylene, Lauryl PEG-10 Tris (Trimethylsiloxy) silylethyl Dimethicone, Aqua (Water), Styrene/Acrylates Copolymer, Triacontanyl PVP, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Pentaerhthrityl Tetraisostearate, Methyl Methacrylate Crosspolymer, Propanediol, Isostearic Acid, Glyceryl Caprylate, CI 77891 (Titanium Dioxide), Polyhydroxystearic Acid, Boron Nitride, 1,2-Hexanediol, Mica, Disteardimonium Hectorite, Glycerin, Sodium Chloride, CI 77492 (Iron Oxides), Bisabolol, Propylene Carbonate, Camellia Sinensis Leaf Extract, Hydrolyzed Keratin, Caprylhydroxamic Acid, Sodium Potassium Aluminum Silicate, Limonene, Citrus Aurantium Bergamia (Bergamot) Leaf Oil, Citrus Aurantium Dulcis (Orange) Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Oil, 7-Dehydrocholesterol, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Maltodextrin, Silica, CI 77491 (Iron Oxides), Anigozanthos Flavidus Flower Extract, Syzygium Luehmannii Fruit Extract, Tin Oxide, Aspalathus Linearis Leaf Extract, Butylene Glycol, Sodium Lactate, Sodium PCA, Melanin, CI 77499 (Iron Oxides), Pentylene Glycol, Ceteareth-25, Linalool, Dimethicone, Magnesium Aspartate, Zinc Gluconate, Cetyl Alcohol, Citronellol, Sodium Hyaluronate, Davidsonia Pruriens Fruit Extract, Sodium Benzoate, Glycine, Ethylhexylglycerin, Potassium Sorbate, Behenic Acid, Ceramide NP, Cholesterol, Copper Gluconate, Fructose, Inositol, Lactic Acid, Niacinamide, Urea, Phenoxyethanol, Citric Acid, Ceramide NS, Serine, Glutamic Acid, Ceramide AP, Ceramide EOP, Ceramide EOS, Asparic Acid, Leucine, Acetyl Tetrapeptide-22, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Propine, Threonine, Valine, Isoleucine, Histidine

Do Not Use (Do not use)
  • On damaged or broken skin.
Drug Facts

Active Ingredient

Zinc Oxide 24%

Package Labeling:

Package Labeling:3ml

Package Labeling:5ml

When Using This Product (When using this product)
  • Keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • Rash occurs.
Keep Out of Reach of Children. (Keep out of reach of children.)
  • If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:27.212943 · Updated: 2026-03-14T23:10:53.901398