Kids®

Kids®
SPL v2
SPL
SPL Set ID 20ebe264-2f79-4eef-b83d-3f09a3ca2898
Route
TOPICAL
Published
Effective Date 2024-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (120 mg)
Inactive Ingredients
Water Isoamyl Laurate Coco-caprylate Calendula Officinalis Flower Viola Tricolor Whole Polyglyceryl-2 Dipolyhydroxystearate Candelilla Wax Starch, Rice Carthamus Tinctorius Seed Oleosomes Polyglyceryl-3 Diisostearate Levulinic Acid Medium-chain Triglycerides Starch, Tapioca Rosemary Coconut Oil Squalane Magnesium Stearate P-anisic Acid Allantoin Mica Panthenol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-02-03

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Drug Facts

Uses

Helps prevent sunburn

  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water
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 or irritation develops and lasts.
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.

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 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
Active Ingredient

Titanium Dioxide 12%

Other Information

Protect the product in this container from excessive heat and direct sunlight. Report serious adverse reactions to: 5933 Bowcroft St. Los Angeles, CA 90016

Inactive Ingredients

Water, isoamyl laurate, coco-caprylate, calendula officinalis extract (calendula), viola tricolor extract (pansy), polyglyceryl-2 dipolyhydroxystearate, euphorbia cerifera (candelilla) wax, glyceryl starch, carthamus tinctorius (safflower) oleosomes, polyglyceryl-3 diisostearate, levulinic acid, glycerin, tapioca starch, rosmarinus officinalis (rosemary) leaf extract, cocos nucifera (coconut) oil, squalane, magnesium stearate, p-anisic acid, mica, allantoin, panthenol.

Principal Display Panel 82 G Tube Label

CALIF♥RNIA KIDS®

TINTED

#supersensitive™

30+

SUNSCREEN LOTION

HIGH PROTECTION

NO ADDED FRAGRANCE

BROAD SPECTRUM

SPF 30+ SUNSCREEN

WATER RESISTANT (80 MINUTES)

FOR BABIES, KIDS + ADULTS

WITH SENSITIVE SKIN

ALLERGY

TESTED

© 2018

NET WT 82 g/2.9 oz.


Structured Label Content

Uses

Helps prevent sunburn

  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water
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 or irritation develops and lasts.
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.

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 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
Active Ingredient (Active ingredient)

Titanium Dioxide 12%

Other Information (Other information)

Protect the product in this container from excessive heat and direct sunlight. Report serious adverse reactions to: 5933 Bowcroft St. Los Angeles, CA 90016

Inactive Ingredients (Inactive ingredients)

Water, isoamyl laurate, coco-caprylate, calendula officinalis extract (calendula), viola tricolor extract (pansy), polyglyceryl-2 dipolyhydroxystearate, euphorbia cerifera (candelilla) wax, glyceryl starch, carthamus tinctorius (safflower) oleosomes, polyglyceryl-3 diisostearate, levulinic acid, glycerin, tapioca starch, rosmarinus officinalis (rosemary) leaf extract, cocos nucifera (coconut) oil, squalane, magnesium stearate, p-anisic acid, mica, allantoin, panthenol.

Principal Display Panel 82 G Tube Label (PRINCIPAL DISPLAY PANEL - 82 g Tube Label)

CALIF♥RNIA KIDS®

TINTED

#supersensitive™

30+

SUNSCREEN LOTION

HIGH PROTECTION

NO ADDED FRAGRANCE

BROAD SPECTRUM

SPF 30+ SUNSCREEN

WATER RESISTANT (80 MINUTES)

FOR BABIES, KIDS + ADULTS

WITH SENSITIVE SKIN

ALLERGY

TESTED

© 2018

NET WT 82 g/2.9 oz.


Advanced Ingredient Data


Raw Label Data

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