THINKBABY CLEAR ZINC SPF 30- zinc oxide lotion

Thinkbaby Clear Zinc by

Drug Labeling and Warnings

Thinkbaby Clear Zinc 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 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 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, Aloe Barbadensis Leaf Juice, Tocopherol, Sodium Hyaluronate, Magnesium Sulfate, Carica Papaya (Papaya) Fruit Extract, Vaccinium Macrocarpon (Cranberry) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Olea Europaea (Olive) Fruit Oil, Rubus Idaeus (Raspberry) Seed Oil, Hydrogenated Castor Oil, Caprylhydroxamic Acid, Triethoxycaprylylsilane, Glyceryl Caprylate.

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

thinkbaby

80
min

water
resistant

dermatologist
recommended

CLEAR ZINC OXIDE
SUNSCREEN

30 SPF

broad spectrum
UVA/UVB

100% mineral

blends in quickly

fragrance-free

EWG VERIFIED
FOR YOUR HEALTH EWG.ORG

3 fl oz 89 ml

INGREDIENTS AND APPEARANCE

THINKBABY CLEAR ZINC   SPF 30
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60781-4175
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)
GLYCERYL ABIETATE (UNII: 2F22LY70Q1)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BISPYRITHIONE MAGSULFEX ANHYDROUS (UNII: 1558D89HVP)
PAPAYA (UNII: KU94FIY6JB)
CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
OLIVE OIL (UNII: 6UYK2W1W1E)
RASPBERRY SEED OIL (UNII: 9S8867952A)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60781-4175-3	89 mL in 1 TUBE; Type 0: Not a Combination Product	07/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M020	07/01/2022

Labeler - thinkOperations,LLC (808883636)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(60781-4175)