THINK ALOE AND TEA LEAVES ZINC OXIDE- zinc oxide lotion

Think Aloe and Tea Leaves by

Drug Labeling and Warnings

Think Aloe and Tea Leaves by is a Otc medication manufactured, distributed, or labeled by thinkOperations,LLC, Topiderm, Inc., Topix Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 20%

Purpose

Sunscreen

Uses

• Helps prevent sunburns
• If used as directed with other sun protection measures (see Directions) 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.

• Stop us 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.

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours when exposed to sun

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, especially from 10 a.m. - 2 p.m
• wear long-sleeved shirts, pants, hats, and sunglasses

For children under 6 months: Ask a doctor

Inactive ingredients

Purified Water, Caprylic/Capric Triglyceride, Polyglyceryl-4 Isostearate, Glycerin, Hydrogenated Glyceryl Abietate, Hexyl Laurate, Cetyl Dimethicone, Sorbitan Sesquioleate, Magnesium Sulfate, Tocopherol, Sodium Hyaluronate, Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Olea Europaea (Olive) Fruit Oil, Citrus Paradisi (Grapefruit) Peel Oil, Aloe Barbadensis Leaf Juice, Hydrogenated Castor Oil, Triethoxycaprylylsilane, Caprylhydroxamic Acid, Glyceryl Caprylate, Natural Fragrance Oil.

Other information

• protect this product from excessive heat and direct sun

For Questions

877.446.1616

SPL UNCLASSIFIED SECTION

Dist.by: Think Operations, LLC
Simi Valley, CA 93065 USA

PRINCIPAL DISPLAY PANEL - 89 ml Tube Label

thinkdaily

EWG
RATED #1
80
min
sweat + water
resistant

ALOE & TEA LEAVES
ZINC OXIDE 20%
SUNSCREEN

30 SPF

free of harmful
chemicals

dermatologist
recommended

antioxidant
protection

easy application

3 fl oz 89 ml

INGREDIENTS AND APPEARANCE

THINK ALOE AND TEA LEAVES   ZINC OXIDE
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60781-4698
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
OLIVE OIL (UNII: 6UYK2W1W1E)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60781-4698-1	89 mL in 1 TUBE; Type 0: Not a Combination Product	07/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	07/02/2022

Labeler - thinkOperations,LLC (808883636)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(60781-4698)

Establishment
Name	Address	ID/FEI	Business Operations
Topix Pharmaceuticals, Inc.		117745066	PACK(60781-4698)