karyng complete spf sunscreen (light/medium)

karyng complete spf sunscreen (light/medium)
SPL v1
SPL
SPL Set ID 33596253-413d-fba3-e063-6394a90a39e4
Route
topical
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (14.5 g) titanium dioxide (5.75 g)
Inactive Ingredients
water dipotassium glycyrrhizate echinacea purpurea silicon dioxide trisodium ethylenediamine disuccinate sodium c14-16 olefin sulfonate glycerin cetearyl glucoside triethoxycaprylylsilane steareth-2 steareth-21 caprylhydroxamic acid caprylyl glycol citrus grandis (grapefruit) peel oil pentylene glycol xanthan gum stearic acid isopropyl palmitate cetearyl alcohol caprylic/capric triglyceride polyhydroxystearic acid (2300 mw) propanediol sodium stearoyl glutamate alumina dicaprylyl carbonate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-04-01

Description

Titanium Dioxide 5.75% Zinc Oxide 14.5%


Medication Information

Warnings and Precautions

For external use only.

Active Ingredient

Titanium Dioxide 5.75%

Zinc Oxide 14.5%

Indications and Usage

Helps prevent sunburn. If used as directed with other sun protection measures (See Sun Alert), decreases the risk of skin cancer and early skinaging by the sun.

Dosage and Administration

Directions:

Apply liberally 15 minutes before sun exposure.

Reapply after 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 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 10am-2pm

Wear long-sleeved shirts, pants, hats and sunglasses

Children under six months of age, ask a doctor

Description

Titanium Dioxide 5.75% Zinc Oxide 14.5%

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if rash or irritation occurs.

Section 50567-7

Do not get into eyes. Rinse with water to remove.

Section 51727-6

Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Glycerin, Steareth-2, Pentylene Glycol, Silica, Steareth-21, Polyhydroxystearic Acid, Cetearyl Alcohol. Echinacea Purpurea Extract. Swertia Chirata Leaf Extract, Citrus Grandis (Grapefruit) Peel Oil, Litsea Cubeba Oil, Copper Lysinate/Prolinate, Dipotassium Glycyrrhizate, Sodium Stearoyl Glutamate, Stearic Acid, Propanediol Cetearyl Glucoside, Methylglucoside Phosphate, Lecithin, Triethoxycaprylylsilane, Isopropyl Palmitate, Sodium C14-16 Olefin Sulfonate, Trisodium Ethylenediamine Disuccinate. Alumina, Xanthan Gum, Caprylhydroxamic Acid, Caprylyl Glycol, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499).

Section 51945-4

Section 54433-8

Sun Alert. Limiting sun exposure, wearing protective clothing, and using suncreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Section 55105-1

Sunscreen

Section 60561-8

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


Structured Label Content

Warnings and Precautions (34071-1)

For external use only.

Active Ingredient (55106-9)

Titanium Dioxide 5.75%

Zinc Oxide 14.5%

Indications and Usage (34067-9)

Helps prevent sunburn. If used as directed with other sun protection measures (See Sun Alert), decreases the risk of skin cancer and early skinaging by the sun.

Dosage and Administration (34068-7)

Directions:

Apply liberally 15 minutes before sun exposure.

Reapply after 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 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 10am-2pm

Wear long-sleeved shirts, pants, hats and sunglasses

Children under six months of age, ask a doctor

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 50566-9 (50566-9)

Stop use and ask a doctor if rash or irritation occurs.

Section 50567-7 (50567-7)

Do not get into eyes. Rinse with water to remove.

Section 51727-6 (51727-6)

Water (Aqua), Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Glycerin, Steareth-2, Pentylene Glycol, Silica, Steareth-21, Polyhydroxystearic Acid, Cetearyl Alcohol. Echinacea Purpurea Extract. Swertia Chirata Leaf Extract, Citrus Grandis (Grapefruit) Peel Oil, Litsea Cubeba Oil, Copper Lysinate/Prolinate, Dipotassium Glycyrrhizate, Sodium Stearoyl Glutamate, Stearic Acid, Propanediol Cetearyl Glucoside, Methylglucoside Phosphate, Lecithin, Triethoxycaprylylsilane, Isopropyl Palmitate, Sodium C14-16 Olefin Sulfonate, Trisodium Ethylenediamine Disuccinate. Alumina, Xanthan Gum, Caprylhydroxamic Acid, Caprylyl Glycol, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499).

Section 51945-4 (51945-4)

Section 54433-8 (54433-8)

Sun Alert. Limiting sun exposure, wearing protective clothing, and using suncreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

Section 55105-1 (55105-1)

Sunscreen

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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