1cb7fbca-0874-ae53-e063-6294a90ab42a

SPL v4

SPL

SPL Set ID 1cb7fbca-0874-ae53-e063-6294a90ab42a

Route

topical

Published

Effective Date 2024-07-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

octocrylene (3000 mg) titanium dioxide (2400 mg) octinoxate (1500 mg) octisalate

Inactive Ingredients

isononyl isononanoate dimethicone phenyl trimethicone propylene carbonate water tricaprilin cetyl peg/ppg-10/1 dimethicone (hlb 5) butylene glycol cyclomethicone 5 hydroxyacetophenone bentoquatam 1,2-hexanediol butylated hydroxytoluene .alpha.-tocopherol glycerin .alpha.-tocopherol acetate aluminum hydroxide dicaprylyl carbonate amino acids, corn gluten magnesium sulfate, unspecified stearic acid disteardimonium hectorite fragrance 13576 magnesium stearate

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-07-11

Purpose

Sunscreen

Description

Octocrylene 10% Ethylhexyl methoxycinnamate 10% Titanium Dioxide 8% Ethylhexyl salicylate 5%

Medication Information

Warnings

For external use only.

Uses

Helps prevent sunburn

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

Purpose

Sunscreen

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.

Other Information

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

Inactive Ingredients

Water, Glycerin, Dicaprylyl Carbonate, lsononyl lsononanoate, 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-18 Bentonite, Hydroxyacetophenone, 1,2-hexanediol, Aluminum Hydroxide, Stearic Acid, Disteardimonium Hectorite, Fragrance, PropyleneCarbonate, BHT, Vitamin E

Description

Octocrylene 10% Ethylhexyl methoxycinnamate 10% Titanium Dioxide 8% Ethylhexyl salicylate 5%

Principal Display Panel

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

Do Not Use

on damaged or broken skin

Shelf Life

3 Years

Precautions

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 value of SPF 15 or higher and other sun protection measures including: limit time in the sun, 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 for Baby SPF50plus

Place of Origin

Made in China

Active Ingredients

Octocrylene 10%

Ethylhexyl methoxycinnamate 10%

Titanium Dioxide 8%

Ethylhexyl salicylate 5%

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 Control Center right away

Structured Label Content

Warnings

For external use only.

Uses

Helps prevent sunburn

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

Purpose

Sunscreen

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.

Other Information (Other information)

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

Inactive Ingredients

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Do Not Use (Do not use)

on damaged or broken skin

Shelf Life

3 Years

Precautions

Manufacturer

Guangzhou Senmai Biotechnology Co.

Product Name

Sunscreen for Baby SPF50plus

Place of Origin

Made in China

Active Ingredients

Octocrylene 10%

Ethylhexyl methoxycinnamate 10%

Titanium Dioxide 8%

Ethylhexyl salicylate 5%

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 Control Center right away

Advanced Ingredient Data

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"classCode": "ACTIB", "strengthNumerator": "2400", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "OCTINOXATE", "unii": "4Y5P7MUD51", "classCode": "ACTIB", "strengthNumerator": "3000", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "OCTISALATE", "unii": "4X49Y0596W", "classCode": "ACTIB", "strengthNumerator": "1500", "strengthDenominator": "30", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRICAPRILIN", "unii": "6P92858988", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)", "unii": "035JKJ76MT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CYCLOMETHICONE 5", "unii": "0THT5PCI0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYACETOPHENONE", "unii": "G1L3HT4CMH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENTOQUATAM", "unii": "7F465U79Q1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "1,2-HEXANEDIOL", "unii": "TR046Y3K1G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALUMINUM HYDROXIDE", "unii": "5QB0T2IUN0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DICAPRYLYL CARBONATE", "unii": "609A3V1SUA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINO ACIDS, CORN GLUTEN", "unii": "0540V8ZD7V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM SULFATE, UNSPECIFIED", "unii": "DE08037SAB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DISTEARDIMONIUM HECTORITE", "unii": "X687XDK09L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FRAGRANCE 13576", "unii": "5EM498GW35", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Helps prevent sunburn If 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": "on damaged or broken skin", "Shelf Life": "3 Years", "Precautions": "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 value of SPF 15 or higher and other sun protection measures including: limit time in the sun, 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 for Baby 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 methoxycinnamate 10% Titanium Dioxide 8% Ethylhexyl salicylate 5%", "Inactive Ingredients": "Water, Glycerin, Dicaprylyl Carbonate, lsononyl lsononanoate, 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-18 Bentonite, Hydroxyacetophenone, 1,2-hexanediol, Aluminum Hydroxide, Stearic Acid, Disteardimonium Hectorite, Fragrance, PropyleneCarbonate, BHT, Vitamin E", "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 Control Center right away"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:15.388284 · Updated: 2026-03-14T23:06:45.911086