SPL v3
SPL
SPL Set ID 1d560670-026b-bd34-e063-6394a90a9af4
Route
TOPICAL
Published
Effective Date 2024-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (1500 mg) Octocrylene (3000 mg) Octinoxate (2400 mg) Titanium Dioxide
Inactive Ingredients
Amino Acids, Corn Gluten Medium-chain Triglycerides Butylene Glycol Phenyl Trimethicone 1,2-hexanediol Aluminum Hydroxide Stearic Acid Disteardimonium Hectorite Fragrance 13576 Propylene Carbonate .alpha.-tocopherol .alpha.-tocopherol Acetate Glycerin Water Dicaprylyl Carbonate Isononyl Isononanoate Dimethicone Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Cyclomethicone 5 Magnesium Sulfate, Unspecified Magnesium Stearate Bentoquatam Hydroxyacetophenone Butylated Hydroxytoluene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-16

Description

Octocrylene 10% Ethylhexyl Methoxycirnnamate 10% Titanium Dioxide 8% Ethylhexyl Salicylate 5%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Octocrylene 10% Ethylhexyl Methoxycirnnamate 10% Titanium Dioxide 8% Ethylhexyl Salicylate 5%

Uses

Helps prevent sunburn

lf used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Address

20-1second floor, 20-2 first to third floor,Dashan Road,Qinghu,Junhe Street, Baiyun district, Guangzhou City, China.

Capacity

30ml/1.05 Fl.oz

Warnings

For external use only

Directions

Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply at least every 2 hours

Do Not Use

on damaged or broken skin

Shelf Life

3 Years

Precautions

Spending timein the sun increasesyour risk ofskin cancer and early skin aging.Todecrease this risk, regularly use a sunscreen with abroad spectrum value of SPF 15 or higher and othersun protection measures including: limit time in thsun,especially from 10 a.m.-2 p.m.wearlong-sleeved shirts, pants, hats, and sunglasses.Children under 6 months of age: Ask a physician.

Manufacturer

Guangzhou Senmai Biotechnology Co.

Product Name

Sunscreen Emulsion SPF50plus

Place of Origin

Made in China

Other Information

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

Active Ingredients

Octocrylene 10%

Ethylhexyl Methoxycirnnamate 10%

Titanium Dioxide 8%

Ethylhexyl Salicylate 5%

Inactive Ingredients

Water, Glycerin, Dicaprylyl Carbonate, Isononyllsononanoate, Caprylic/capric Triglyceride, Dimethicone, Ceryl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Phenyl Trimethicone,Cyclopentasiloxane,Corn Gluten Amino Acids, Magnesium Stearate,Magnesium Sulfate,Tocopheryl Acetate, Quaternium-18Bentonite, Hydroxyacetophenone, 1,2-hexanediol, Aluminum Hydroxide, Stearic Acid,

Disteardimonium Hectorite,Fragrance,Propylene Carbonate,BHT,Vitamin E

Principal Display Panel

When Using This Product

Keep out of eyes. Rinse with water to remove. Stop and ask a doctor if rash occurs.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Conirol Center right away


Structured Label Content

Uses

Helps prevent sunburn

lf used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.

Address

20-1second floor, 20-2 first to third floor,Dashan Road,Qinghu,Junhe Street, Baiyun district, Guangzhou City, China.

Purpose

Sunscreen

Capacity

30ml/1.05 Fl.oz

Warnings

For external use only

Directions

Apply to face and neck, avoiding the eye area. Wait at least 30 minutes before sun exposure, or as directed by a physician. Reapply at least every 2 hours

Do Not Use (Do not use)

on damaged or broken skin

Shelf Life

3 Years

Precautions

Spending timein the sun increasesyour risk ofskin cancer and early skin aging.Todecrease this risk, regularly use a sunscreen with abroad spectrum value of SPF 15 or higher and othersun protection measures including: limit time in thsun,especially from 10 a.m.-2 p.m.wearlong-sleeved shirts, pants, hats, and sunglasses.Children under 6 months of age: Ask a physician.

Manufacturer

Guangzhou Senmai Biotechnology Co.

Product Name

Sunscreen Emulsion SPF50plus

Place of Origin

Made in China

Other Information (Other information)

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

Active Ingredients (Active ingredients)

Octocrylene 10%

Ethylhexyl Methoxycirnnamate 10%

Titanium Dioxide 8%

Ethylhexyl Salicylate 5%

Inactive Ingredients

Water, Glycerin, Dicaprylyl Carbonate, Isononyllsononanoate, Caprylic/capric Triglyceride, Dimethicone, Ceryl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Phenyl Trimethicone,Cyclopentasiloxane,Corn Gluten Amino Acids, Magnesium Stearate,Magnesium Sulfate,Tocopheryl Acetate, Quaternium-18Bentonite, Hydroxyacetophenone, 1,2-hexanediol, Aluminum Hydroxide, Stearic Acid,

Disteardimonium Hectorite,Fragrance,Propylene Carbonate,BHT,Vitamin E

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When using this product)

Keep out of eyes. Rinse with water to remove. Stop 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 Conirol Center right away


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)