thinkbaby®

thinkbaby®
SPL v3
SPL
SPL Set ID f2788a1a-daf6-4b7d-8333-585a380ebe57
Route
topical
Published
Effective Date 2024-06-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (234 mg)
Inactive Ingredients
water medium-chain triglycerides polyglyceryl-4 isostearate glycerin hydrogenated methyl abietate hexyl laurate cetyl dimethicone 150 hydrogenated castor oil magnesium sulfate anhydrous sunflower oil jojoba oil .alpha.-tocopherol olive oil raspberry seed oil hyaluronate sodium papaya juice citrus paradisi fruit oil sorbitan sesquioleate caprylhydroxamic acid triethoxycaprylylsilane glyceryl monocaprylate cranberry seed oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-09-02

Purpose

Sunscreen

Description

Drug Facts


Medication Information

Warnings
  • For external use only.
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
Purpose

Sunscreen

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
Other Information
  • Protect this product from excessive heat and direct sun.
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.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9
  • Stop use and ask a doctor if rash occurs.
Section 50570-1
  • Do not use on damaged or broken skin.
For Questions

877.446.1616

Active Ingredient

Zinc Oxide 23.4%

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


Structured Label Content

Warnings
  • For external use only.
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
Purpose

Sunscreen

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
Other Information (Other information)
  • Protect this product from excessive heat and direct sun.
Inactive Ingredients (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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if rash occurs.
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin.
For Questions

877.446.1616

Active Ingredient

Zinc Oxide 23.4%

Principal Display Panel 177 Ml Tube Label (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)