Kidcrème

Kidcrème
SPL v2
SPL
SPL Set ID 4f0bf232-645a-4f69-b386-3a138a5c9964
Route
TOPICAL
Published
Effective Date 2018-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (2.7 g) Zinc Oxide (1.3 g)
Inactive Ingredients
Dimethicone Dimethicone/diene Dimethicone Crosspolymer Medium-chain Triglycerides Glyceryl Isostearate Polyhydroxystearic Acid (2300 Mw) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Silicon Dioxide Butyloctyl Salicylate Polysilicone-15 Tetrahexyldecyl Ascorbate Green Tea Leaf Cranberry Pomegranate Juice Ferric Oxide Red Peg/ppg-18/18 Dimethicone Triethoxycaprylylsilane Ubidecarenone .alpha.-tocopherol Acetate Squalane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-06-16

Description

Drug Facts


Medication Information

Description

Drug Facts

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.
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 50567-7

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin

Section 55105-1
Active Ingredients Purpose
Titanium Dioxide 2% Sunscreen
Zinc Oxide 17% 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: Ask a doctor
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10a.m.-2p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses
Other Information

Shake well. Rub in well.

  • Protect the product in this container from excessive heat and direct sunlight
  • May stain some fabrics
  • You may report serious adverse reactions to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222
Inactive Ingredients

Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Dimethicone/ Vinyl Dimethicone Crosspolymer, Silica, Butyl Octyl Salicylate Polysilicone-15, Tetrahexyldecyl Ascorbate, Camellia Sinensis (Green Tea) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum (Pomegranate) Extract, Iron oxide, PEG/PPG-18/18 Dimethicone, Triethoxy-caprylylsilane, Ubiquinone, Tocopheryl Acetate, Squalane

Principal Display Panel 71 G Tube Carton

MDSolarSciences

40

KidCrème

MINERAL SUNSCREEN

BROAD SPECTRUM

SPF 40

UVA-UVB SUNSCREEN

Gentle enough for sensitive skin

Safe for children

6 months and older

Dermatologist developed,

approved & recommended

Water resistant (80 minutes)

Non-Comedogenic–Won't clog pores

Oil-Free–Fragrance-Free

sun care

Net Wt. 71g -2.54Oz


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.
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 50567-7 (50567-7)

When using this product keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Section 55105-1 (55105-1)
Active Ingredients Purpose
Titanium Dioxide 2% Sunscreen
Zinc Oxide 17% 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: Ask a doctor
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10a.m.-2p.m.
    • Wear long-sleeved shirts, pants, hats and sunglasses
Other Information

Shake well. Rub in well.

  • Protect the product in this container from excessive heat and direct sunlight
  • May stain some fabrics
  • You may report serious adverse reactions to: Report Reaction, LLC. PO Box 22, Plainsboro, NJ 08536-0222
Inactive Ingredients

Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Glyceryl Isostearate, Polyhydroxystearic Acid, Dimethicone/ Vinyl Dimethicone Crosspolymer, Silica, Butyl Octyl Salicylate Polysilicone-15, Tetrahexyldecyl Ascorbate, Camellia Sinensis (Green Tea) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum (Pomegranate) Extract, Iron oxide, PEG/PPG-18/18 Dimethicone, Triethoxy-caprylylsilane, Ubiquinone, Tocopheryl Acetate, Squalane

Principal Display Panel 71 G Tube Carton (PRINCIPAL DISPLAY PANEL - 71 g Tube Carton)

MDSolarSciences

40

KidCrème

MINERAL SUNSCREEN

BROAD SPECTRUM

SPF 40

UVA-UVB SUNSCREEN

Gentle enough for sensitive skin

Safe for children

6 months and older

Dermatologist developed,

approved & recommended

Water resistant (80 minutes)

Non-Comedogenic–Won't clog pores

Oil-Free–Fragrance-Free

sun care

Net Wt. 71g -2.54Oz


Advanced Ingredient Data


Raw Label Data

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