Thinkbaby Lotion
FDA Label NDC 60781-4417

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Thinkoperations,llc for the product Thinkbaby (NDC 60781-4417). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

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.

Otc - Do Not Use

  • Do not use on damaged or broken skin.

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

  • 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

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

Principal Display Panel (177 ml Tube Label)

Principal Display Panel (177 ml Tube Label)

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