Tinted Facial Sunscreen

Tinted Facial Sunscreen
SPL v4
SPL
SPL Set ID 1259035e-9196-97de-e063-6394a90a9dec
Route
TOPICAL
Published
Effective Date 2024-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (5.6 mg) Zinc Oxide (11 mg)
Inactive Ingredients
Ethylhexyl Palmitate Dimethicone Phenyl Trimethicone Disteardimonium Hectorite Sodium Chloride Glycerin Hydrogenated Polydecene (1500 Cst) Cetyl Peg/ppg-10/1 Dimethicone (hlb 3) Sodium Pyrrolidone Carboxylate Panthenol Ferric Oxide Red Triethoxycaprylylsilane Polyhydroxystearic Acid (2300 Mw) Magnesium Stearate Ethylhexylglycerin Centella Asiatica Triterpenoids Glycyrrhiza Glabra Hibiscus Mutabilis Flower Tribehenin Ferric Oxide Yellow Alpha-tocopherol Acetate Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Jojoba Oil Scutellaria Baicalensis Root Prunus Mume Flower Rosemary Chamomile P-anisic Acid Butylene Glycol Silicon Dioxide Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Squalane Saccharide Isomerate Hyaluronic Acid Silanetriol Sodium Levulinate Green Tea Leaf Nelumbo Nucifera Flower 1,2-hexanediol Polyglyceryl-3 Diisostearate 2-ethylhexyl Acrylate, Methacrylate, Methyl Methacrylate, Or Butyl Methacrylate/hydroxypropyl Dimethicone Copolymer (30000-300000 Mw) Peg-30 Dipolyhydroxystearate Phenoxyethanol Ferrosoferric Oxide Methylpropanediol Polygonum Cuspidatum Root Prunus Persica Flower Isononyl Isononanoate Citric Acid Monohydrate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-21

Description

Zinc Oxide 11%. Titanium Dioxide 5.6%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

helps prevent sunburnifused as directed with other sun protection measures (seeDirections),decreases the risk of skin cancer and early skinaging caused by the sun

Dosage and Administration

Directions

apply liberally 15 minutes before sun exposure

reapply: after 80 minutes of swimming or sweating

immediately after towel drying at least every 2 hours

children under 6 months of age: ask a doctor Sun Protection Measures. Spendingtime in the sun increases your risk of skin cancer and early skin aging

thisrisk, regularly use a sunscreen with a Broad Spertrum SPF of 15 or higher

limit time in the sun, especially from 10 a.m.-2 p.m.

wear long-sleeved shirts,pants,hats and sunglasses.

Children under 6 months of age : Ask a doctor.

Description

Zinc Oxide 11%. Titanium Dioxide 5.6%

Section 50565-1

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 51727-6

Water, lsononyl lsononanoate, Dimethicone, Butylene GlycolGlycerin, Ethylhexyl Palmitate, Phenyl Trimethicone,Hydrogenated Polydecene, Polyglyceryl-3 Diisostearate, CetyPeg/Ppg-10/1 Dimethicone, Silica, DisteardimoniumHectorite, Polyhydroxystearic Acid, Sodium Chloride.Acrylates/Dimethicone Copolymer, Dimethicone/VinylDimethicone Crosspolymer, Sodium Pca, Peg-30Dipolyhydroxystearate, Tribehenin, Magnesium Stearate, Ci77492,Phenoxyethanol, Panthenol, Tocopheryl Acetate, Ci77491, Ethylhexylglycerin, Ci77499, Triethoxycaprylylsilane,PentaerythritylTetra-Di-T-Butyl Hydroxyhydrocinnamate,Simmondsia Chinensis (Jojoba) Seed Oil, Squalane.Saccharide lsomerate, Methylpropanediol, Centella AsiaticaExtract, Polygonum Cuspidatum Root Extract, ScutellariaBaicalensis Root Extract, Camellia Sinensis Leaf Extract,Hibiscus Mutabilis Flower Extract,Nelumbium SpeciosumFlower Extract,1.2-Hexanediol,Rosmarinus Officinalis(Rosemary) Leaf Extract, Chamomilla Recutita (MatricariaFlower Exiract, Hyaluronic Acid, Sodium Levulinate,Silanetriol, Citric Acid, P-Anisic Acid

Section 51945-4

Section 53413-1

You can email us at [email protected] for more help!

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide 11%.

Titanium Dioxide 5.6%

Section 60561-8

Protect the product in this container from excessive heat and direct sun


Structured Label Content

Indications and Usage (34067-9)

helps prevent sunburnifused as directed with other sun protection measures (seeDirections),decreases the risk of skin cancer and early skinaging caused by the sun

Dosage and Administration (34068-7)

Directions

apply liberally 15 minutes before sun exposure

reapply: after 80 minutes of swimming or sweating

immediately after towel drying at least every 2 hours

children under 6 months of age: ask a doctor Sun Protection Measures. Spendingtime in the sun increases your risk of skin cancer and early skin aging

thisrisk, regularly use a sunscreen with a Broad Spertrum SPF of 15 or higher

limit time in the sun, especially from 10 a.m.-2 p.m.

wear long-sleeved shirts,pants,hats and sunglasses.

Children under 6 months of age : Ask a doctor.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 51727-6 (51727-6)

Water, lsononyl lsononanoate, Dimethicone, Butylene GlycolGlycerin, Ethylhexyl Palmitate, Phenyl Trimethicone,Hydrogenated Polydecene, Polyglyceryl-3 Diisostearate, CetyPeg/Ppg-10/1 Dimethicone, Silica, DisteardimoniumHectorite, Polyhydroxystearic Acid, Sodium Chloride.Acrylates/Dimethicone Copolymer, Dimethicone/VinylDimethicone Crosspolymer, Sodium Pca, Peg-30Dipolyhydroxystearate, Tribehenin, Magnesium Stearate, Ci77492,Phenoxyethanol, Panthenol, Tocopheryl Acetate, Ci77491, Ethylhexylglycerin, Ci77499, Triethoxycaprylylsilane,PentaerythritylTetra-Di-T-Butyl Hydroxyhydrocinnamate,Simmondsia Chinensis (Jojoba) Seed Oil, Squalane.Saccharide lsomerate, Methylpropanediol, Centella AsiaticaExtract, Polygonum Cuspidatum Root Extract, ScutellariaBaicalensis Root Extract, Camellia Sinensis Leaf Extract,Hibiscus Mutabilis Flower Extract,Nelumbium SpeciosumFlower Extract,1.2-Hexanediol,Rosmarinus Officinalis(Rosemary) Leaf Extract, Chamomilla Recutita (MatricariaFlower Exiract, Hyaluronic Acid, Sodium Levulinate,Silanetriol, Citric Acid, P-Anisic Acid

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

You can email us at [email protected] for more help!

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide 11%.

Titanium Dioxide 5.6%

Section 60561-8 (60561-8)

Protect the product in this container from excessive heat and direct sun


Advanced Ingredient Data


Raw Label Data

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