THINKBABY SPF 50- zinc oxide lotion

Thinkbaby by

Drug Labeling and Warnings

Thinkbaby by is a Otc medication manufactured, distributed, or labeled by thinkOperations,LLC, Topiderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Zinc Oxide 23.4%

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 use 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, Vaccinium Macrocarpon (Cranberry) Seed Oil, Rubus Idaeus (Raspberry) Seed Oil, Carica Papaya (Papaya) Fruit Extract, Hydrogenated Castor Oil, Caprylhydroxamic Acid, Triethoxycaprylylsilane, 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 - 177 ml Tube Label

thinkbaby®

80
min

water
resistant

free of harmful
chemicals

ZINC OXIDE 23.4%
SUNSCREEN

50 SPF

broad spectrum
UVA/UVB

dermatologist
recommended

hypoallergenic

reef friendly

6 fl oz 177 ml

INGREDIENTS AND APPEARANCE

THINKBABY  SPF 50
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60781-4417
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	234 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)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
OLIVE OIL (UNII: 6UYK2W1W1E)
RASPBERRY SEED OIL (UNII: 9S8867952A)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PAPAYA JUICE (UNII: AZ5XLY17KM)
CITRUS PARADISI FRUIT OIL (UNII: 6A7N43E0OJ)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60781-4417-6	177 mL in 1 TUBE; Type 0: Not a Combination Product	09/02/2022
2	NDC: 60781-4417-3	89 mL in 1 TUBE; Type 0: Not a Combination Product	09/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	09/02/2022

Labeler - thinkOperations,LLC (808883636)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(60781-4417)