TBS ALOE SPF15 by Meiyume TBS ALOE SPF15

TBS ALOE SPF15 by

Drug Labeling and Warnings

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

Drug Details [pdf]

TBS ALOE SPF15- avobenzone lotion 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 ALOE 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.

If product is swallowed get medical help or contact a Poison Control Center right away.

* Apply liberally 15 minutes before sun exposure.

* 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 especailly from 10 a.m. - 2 p.m.

* wear long-sleeved shirts, pants, hats and sunglasses.

* reapply this product at least every 2 hours.

* use a water resistant sunscreen if swimming or sweating.

* children under 6months 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, Sesamum Indicum (Sesame) Seed Oil, Dimethicone, Phenoxyethanol, Caprylyl Glycol, Panthenol, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Leaf Juice Powder, Xanthan Gum, Carbomer, Bisabolol, Potassium Sorbate, Tetrasodium EDTA, Sodium Hydroxide, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Pentylene Glycol, BHT, Avena Sativa (Oat) Kernel Extract, Citric Acid.

THE BODY SHOP®

THE BODY SHOP

ALOE

SOOTHING MOISTURE LOTION

BROAD SPECTRUM SUNSCREEN SPF15

FRAGRANCE-FREE, COLOURANT-FREE,

PARABEN-FREE, ALCOHOL-FREE

WITH PURE, HAND-FILLETED ALOE FROM CAMPECHE, MEXICO

50mL (1.69 US FL OZ)

FORMULATED FOR

SENSITIVE SKIN

TBS ALOE SPF15 
avobenzone lotion lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51280-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.03 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.05 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
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
XANTHAN GUM (UNII: TTV12P4NEE)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
.ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
OAT (UNII: Z6J799EAJK)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SESAME OIL (UNII: QX10HYY4QV)
DIMETHICONE (UNII: 92RU3N3Y1O)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETATE SODIUM (UNII: MP1J8420LU)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51280-006-50	50 g in 1 TUBE; Type 0: Not a Combination Product	12/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/22/2020

Labeler - Meiyume (225596238)

Registrant - Meiyume (225596238)

Establishment
Name	Address	ID/FEI	Business Operations
Meiyume		225596238	manufacture(51280-006) , pack(51280-006)

Revised: 12/2022

Document Id: eedb70e0-2688-49fd-e053-2a95a90a36f6

34390-5

Set id: b70db766-c120-aa1e-e053-2a95a90ab257

Version: 3

Effective Time: 20221202