84326-001_dear Sun Tone Perfecting Spf Cushion

84326-001_dear Sun Tone Perfecting Spf Cushion
SPL v2
SPL
SPL Set ID 80748647-e0ea-46dc-8ee2-a0ad77c4b19d
Route
TOPICAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (10 g) Octisalate (3 g) Octocrylene (2 g) Zinc Cation (13.3 g)
Inactive Ingredients
Water Butyloctyl Salicylate Glycerin Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Alkyl (c12-15) Benzoate Niacinamide Cyclomethicone 5 Silicon Dioxide Sodium Chloride Polyhydroxystearic Acid (2300 Mw) 1,2-hexanediol Triethoxycaprylylsilane Disteardimonium Hectorite Ceresin Propylene Carbonate Trihydroxystearin Ethylhexylglycerin Caprylyl Glycol Butylene Glycol Medium-chain Triglycerides Centella Asiatica Triterpenoids Sucrose Stearate Ferric Oxide Yellow Cetostearyl Alcohol Ferric Oxide Red Tocopherol Madecassoside Madecassic Acid Asiaticoside Asiatic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-01

Description

Homosalate 10.00% Octisalate 3.00% Octocrylene 2.00% Zinc Oxide 13.30%


Medication Information

Warnings and Precautions

For external use only

Do not useon demaged or broken skin. 

Stop use and ask a doctorif rash occurs.

■ When using this productkeep out of eyes. Rinse with water to remove.

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

Indications and Usage

Helps prevent sunburn

If used as directed with other sun protection ,easure (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration

■ apply liberally 15 minutes before sun exposure

■ use a water resistant sunscreen if swimming or sweating.

■ reapply at least every 2 hours.

■ children under 6 months of age: ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.

■ 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. – 2 p.m.

– Wear long-sleeved shirts, pants, hats and sunglasses

Description

Homosalate 10.00% Octisalate 3.00% Octocrylene 2.00% Zinc Oxide 13.30%

Section 50565-1

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6

Water, Butyloctyl Salicylate, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, C12-15 Alkyl Benzoate, Niacinamide, Cyclopentasiloxane, Silica, Sodium Chloride, Polyhydroxystearic Acid, 1,2-Hexanediol, Triethoxycaprylylsilane, Disteardimonium Hectorite, Ceresin, Fragrance, Propylene Carbonate, Trihydroxystearin, Ethylhexylglycerin, Caprylyl Glycol, Butylene Glycol, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Centella Asiatica Extract, Sucrose Stearate, Iron Oxides (CI 77492), Cetearyl Alcohol, Iron Oxides (CI 77491), Tocopherol, Madecassoside, Madecassic Acid, Asiaticoside, Asiatic Acid

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Homosalate 10.00%

Octisalate 3.00%

Octocrylene 2.00%

Zinc Oxide 13.30%

Section 60561-8

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


Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

If used as directed with other sun protection ,easure (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and Administration (34068-7)

■ apply liberally 15 minutes before sun exposure

■ use a water resistant sunscreen if swimming or sweating.

■ reapply at least every 2 hours.

■ children under 6 months of age: ask a doctor

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging.

■ 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. – 2 p.m.

– Wear long-sleeved shirts, pants, hats and sunglasses

Warnings and Precautions (34071-1)

For external use only

Do not useon demaged or broken skin. 

Stop use and ask a doctorif rash occurs.

■ When using this productkeep out of eyes. Rinse with water to remove.

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

Section 50565-1 (50565-1)

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Water, Butyloctyl Salicylate, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, C12-15 Alkyl Benzoate, Niacinamide, Cyclopentasiloxane, Silica, Sodium Chloride, Polyhydroxystearic Acid, 1,2-Hexanediol, Triethoxycaprylylsilane, Disteardimonium Hectorite, Ceresin, Fragrance, Propylene Carbonate, Trihydroxystearin, Ethylhexylglycerin, Caprylyl Glycol, Butylene Glycol, Caprylic/Capric Triglyceride, Hydrogenated Phosphatidylcholine, Centella Asiatica Extract, Sucrose Stearate, Iron Oxides (CI 77492), Cetearyl Alcohol, Iron Oxides (CI 77491), Tocopherol, Madecassoside, Madecassic Acid, Asiaticoside, Asiatic Acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Homosalate 10.00%

Octisalate 3.00%

Octocrylene 2.00%

Zinc Oxide 13.30%

Section 60561-8 (60561-8)

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


Advanced Ingredient Data


Raw Label Data

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