sonage - spf 30 roux tinted day crème (15-ec-080)

sonage - spf 30 roux tinted day crème (15-ec-080)
SPL v2
SPL
SPL Set ID fd14d70c-6cd0-5de6-e053-6294a90a7add
Route
topical
Published
Effective Date 2023-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (13 g)
Inactive Ingredients
trehalose sorbitan monopalmitate green tea leaf caprylhydroxamic acid levomenol cetostearyl alcohol glycerin medium-chain triglycerides cetyl palmitate citric acid monohydrate coco glucoside bergamot oil polyhydroxystearic acid (2300 mw) sodium gluconate hyaluronate sodium caprylyl glycol propanediol squalane aloe vera leaf arachidyl alcohol arachidyl glucoside docosanol butyloctyl salicylate xanthan gum water sodium stearoyl glutamate tocopherol niacinamide ceramide np ethyl ferulate astrocaryum aculeatum seed oil palmitoyl hexapeptide-12 jojoba oil sorbitan olivate ferric oxide yellow ferric oxide red ferrosoferric oxide pogostemon cablin leaf oil cedrus atlantica wood oil neopentyl glycol diheptanoate octyldodecyl oleate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-06-08

Description

Zinc Oxide - 13.0%


Medication Information

Warnings

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Active Ingredient

Zinc Oxide - 13.0%

Uses

Helps prevent sunburn

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

Directions

Apply liberally 15 minutes before sun exposure.

Use a water resistant sunscreen if swimming or sweating

Rapply at least every 2 hours.

Children under 6 monts: 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. to 2 p.m. Wear long-sleeved shirts, pants, hats, and sun glasses.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Arachidyl Alcohol, Arachidyl Glucoside, Astrocaryum Tucuma Seed Butter, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Leaf Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cedrus Alantica Wood (Cedarwood) Oil, Ceramide NP, Cetearyl Alcohol, Cetyl Palmitate, Citric Acid, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Coco-Glucoside, Ethyl Ferulate, Glycerin, Iron Oxides, Neopentyl Glycol Diheptanoate, Niacinamide, Octyldodecyl Oleate, Palmitoyl Hexapeptide-12, Pogostemon Cablin (Patchouli) Oil, Polyhydroxystearic Acid, Propanediol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Sorbitan Olivate, Sorbitan Palmitate, Squalane, Tocopherol, Trehalose, Water, Xanthan Gum

Description

Zinc Oxide - 13.0%

Section 50565-1

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

Section 51945-4

Section 55105-1

Sunscreen


Structured Label Content

Warnings

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Active Ingredient (55106-9)

Zinc Oxide - 13.0%

Uses

Helps prevent sunburn

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

Directions

Apply liberally 15 minutes before sun exposure.

Use a water resistant sunscreen if swimming or sweating

Rapply at least every 2 hours.

Children under 6 monts: 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. to 2 p.m. Wear long-sleeved shirts, pants, hats, and sun glasses.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Arachidyl Alcohol, Arachidyl Glucoside, Astrocaryum Tucuma Seed Butter, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Leaf Extract, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cedrus Alantica Wood (Cedarwood) Oil, Ceramide NP, Cetearyl Alcohol, Cetyl Palmitate, Citric Acid, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Coco-Glucoside, Ethyl Ferulate, Glycerin, Iron Oxides, Neopentyl Glycol Diheptanoate, Niacinamide, Octyldodecyl Oleate, Palmitoyl Hexapeptide-12, Pogostemon Cablin (Patchouli) Oil, Polyhydroxystearic Acid, Propanediol, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Gluconate, Sodium Hyaluronate, Sodium Stearoyl Glutamate, Sorbitan Olivate, Sorbitan Palmitate, Squalane, Tocopherol, Trehalose, Water, Xanthan Gum

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen


Advanced Ingredient Data


Raw Label Data

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