TBS Seaweed SPF15 by Meiyume / Lornamead TBS Seaweed SPF15

TBS Seaweed SPF15 by

Drug Labeling and Warnings

TBS Seaweed SPF15 by is a Otc medication manufactured, distributed, or labeled by Meiyume, Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TBS SEAWEED SPF15- avobenzone lotion 
Meiyume

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TBS Seaweed SPF15

Avobenzone (3.0% w/w)

Octinoxate (2.9% w/w)

Octisalate (5.0% w/w)

Octocrylene (2.2% w/w)

Sunscreen

Sunscreen

Sunscreen

Sunscreen

helps prevent sunburn

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.

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

Apply liberally 15 minutes before sun exposure. * Sun Protection Measures. Spending time in teh 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 sun especially from 10 a.m. - 2 p.m. * wear long-sleeved shirts, pants, hats and sunglasses. * reapply this product at least every 2 hours. * use water resistant sunscreen if swimming or sweating. * children under 6 months of age: ask a doctor.

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

Water, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, Butylene Glycol, Caprylic/Capric Triglyceride, Sorbitol, Cetearyl Alcohol, Potassium Cetyl Phosphate, Dimethicone, Phenoxyethanol, Bertholletia Excelsa Seed Oil, Caprylyl Glycol, Fragrance, Xanthan Gum, Carbomer, Potassium Sorbate, Tetrasodium EDTA, Pentylene Glycol, Propylene Glycol, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fucus Vesiculosus Extract, Linalool, Zinc Gluconate, Benzyl Salicylate, Acacia Senegal Gum, Hydrolyzed Wheat Protein, Propylene Glycol Alginate, BHT, Hydrolyzed Algin, Serine, Sodium Stearate, Zinc Sulfate.

TBS SEAWEED SPF15 
avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51280-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.029 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.022 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE SODIUM (UNII: MP1J8420LU)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
PROPYLENE GLYCOL ALGINATE (UNII: 26CD3J2R0C)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM STEARATE (UNII: QU7E2XA9TG)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FUCUS VESICULOSUS (UNII: 535G2ABX9M)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
ACACIA (UNII: 5C5403N26O)
SODIUM ALGINATE (UNII: C269C4G2ZQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BRAZIL NUT OIL (UNII: 0G89T29HO6)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
ZINC SULFATE (UNII: 89DS0H96TB)
SERINE (UNII: 452VLY9402)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51280-007-50	50 g in 1 TUBE; Type 0: Not a Combination Product	12/21/2020	11/08/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/21/2020	11/08/2022

Labeler - Meiyume (225596238)

Registrant - Meiyume (225596238)

Establishment
Name	Address	ID/FEI	Business Operations
Meiyume		225596238	manufacture(51280-007) , pack(51280-007)

Revised: 12/2022

Document Id: eed5a4c1-0441-6db6-e053-2995a90a0238

34390-5

Set id: b6fae78e-d0d3-aac6-e053-2a95a90a4fcd

Version: 6

Effective Time: 20221202