SUNSCREEN EMULSION SPF50PLUS- octocrylene,ethylhexyl methoxycirnnamate,titanium dioxide,ethylhexyl salicylate lotion

Sunscreen Emulsion SPF50plus by

Drug Labeling and Warnings

Sunscreen Emulsion SPF50plus by is a Otc medication manufactured, distributed, or labeled by Guangzhou Senmai Biotechnology Co., Dongguan Xiaogoubeige trading company Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octocrylene 10%
Ethylhexyl Methoxycirnnamate 10%

Titanium Dioxide 8%
Ethylhexyl Salicylate 5%

Purpose

Sunscreen

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.

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 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

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

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.

Other information

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

Product Name

Sunscreen Emulsion SPF50plus

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

Manufacturer

Guangzhou Senmai Biotechnology Co.

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

Shelf Life

3 Years

Place of Origin

Made in China

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNSCREEN EMULSION SPF50PLUS 
octocrylene,ethylhexyl methoxycirnnamate,titanium dioxide,ethylhexyl salicylate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84509-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1500 mg  in 30 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	3000 mg  in 30 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3000 mg  in 30 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2400 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
AMINO ACIDS, CORN GLUTEN (UNII: 0540V8ZD7V)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
FRAGRANCE 13576 (UNII: 5EM498GW35)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB)
MAGNESIUM STEARATE (UNII: 70097M6I30)
BENTOQUATAM (UNII: 7F465U79Q1)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84509-002-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/16/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/16/2024

Labeler - Guangzhou Senmai Biotechnology Co. (707735253)

Registrant - Dongguan Xiaogoubeige trading company Ltd. (707735253)

Establishment
Name	Address	ID/FEI	Business Operations
Dongguan Xiaogoubeige trading company Ltd.		707735253	manufacture(84509-002) , label(84509-002)