Simple Truth Kids' Mineral Based Stick Spf 50 Sunscreen

Simple Truth Kids' Mineral Based Stick Spf 50 Sunscreen
SPL v4
SPL
SPL Set ID a4e6936d-a76c-e8fd-e053-2995a90a965f
Route
TOPICAL
Published
Effective Date 2020-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (70 mg) Zinc Oxide (47 mg)
Inactive Ingredients
Isopropyl Palmitate Butyloctyl Salicylate Cetyl Alcohol Candelilla Wax Neopentyl Glycol Diethylhexanoate Ceresin White Wax Caprylyl Glycol Isostearic Acid Paraffin Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-06

Description

Titanium Dioxide 7.0%, Zinc Oxide 4.7%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 7.0%, Zinc Oxide 4.7%

Uses
  • helps prevent sunburn
  • 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
Label

SIMPLE TRUTH KIDS' MINERAL BASED STICK SPF 50 SUNSCREEN

30142-881-01

SIMPLE TRUTH KIDS' MINERAL BASED STICK SPF 50 SUNSCREEN BLISTER PACK

30142-881-91

Warnings

For external use only

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
    • children under 6 months of age: ask a doctor
    • 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 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-sleeve shirts, pants, hats, and sunglasses
Do Not Use
  • on damaged or broken skin.
Other Information
  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients

Titanium Dioxide 7.0%, Zinc Oxide 4.7%

Inactive Ingredients

beeswax, butyloctyl salicylate, caprylyl glycol, cetyl alcohol, euphorbia cerifera (candelilla) wax, isopropyl palmitate, isostearic acid, neopentyl glycol diethylhexanoate, ozokerite, paraffin, silica

When Using This Product

keep out of eyes. Rinse with water to remove.

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.


Structured Label Content

Uses
  • helps prevent sunburn
  • 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
Label

SIMPLE TRUTH KIDS' MINERAL BASED STICK SPF 50 SUNSCREEN

30142-881-01

SIMPLE TRUTH KIDS' MINERAL BASED STICK SPF 50 SUNSCREEN BLISTER PACK

30142-881-91

Purpose

Sunscreen

Warnings

For external use only

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
    • children under 6 months of age: ask a doctor
    • 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 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-sleeve shirts, pants, hats, and sunglasses
Do Not Use (Do not use)
  • on damaged or broken skin.
Other Information (Other information)
  • protect this product from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces
Active Ingredients (Active ingredients)

Titanium Dioxide 7.0%, Zinc Oxide 4.7%

Inactive Ingredients (Inactive ingredients)

beeswax, butyloctyl salicylate, caprylyl glycol, cetyl alcohol, euphorbia cerifera (candelilla) wax, isopropyl palmitate, isostearic acid, neopentyl glycol diethylhexanoate, ozokerite, paraffin, silica

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs.
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.


Advanced Ingredient Data


Raw Label Data

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