spf30 calendula™ sunscreen lotion

spf30 calendula™ sunscreen lotion
SPL v2
SPL
SPL Set ID 64580be7-868c-40fb-b7b8-840b417b25d3
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 clary sage oil tea tree oil lavender oil gardenia taitensis flower panthenol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2012-12-01

Purpose

Sunscreen

Description

Drug Facts


Medication Information

Warnings

For external use only

Uses

Helps prevent sunburn

  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water
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
  • 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
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, calendula officinalis extract (calendula), isoamyl laurate, coco-caprylate, 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, lavandula angustifolia (lavender) oil, salvia sclarea (clary) oil, allantoin, panthenol.

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 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.

Active Ingredient

Titanium Dioxide 12%

Stop Use and Ask A Doctor If
  • rash or irritation develops and lasts.
Principal Display Panel 82 G Tube Label

CALIF♥RNIA BABY®

TRUSTED SINCE 1995

calendula™

30+

SUNSCREEN LOTION

HIGH PROTECTION

SUPER GENTLE & SOOTHING

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

Warnings

For external use only

Uses

Helps prevent sunburn

  • higher SPF gives more sunburn protection
  • retains SPF after 80 minutes of activity in the water
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
  • 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
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, calendula officinalis extract (calendula), isoamyl laurate, coco-caprylate, 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, lavandula angustifolia (lavender) oil, salvia sclarea (clary) oil, allantoin, panthenol.

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 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.

Active Ingredient (Active ingredient)

Titanium Dioxide 12%

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash or irritation develops and lasts.
Principal Display Panel 82 G Tube Label (PRINCIPAL DISPLAY PANEL - 82 g Tube Label)

CALIF♥RNIA BABY®

TRUSTED SINCE 1995

calendula™

30+

SUNSCREEN LOTION

HIGH PROTECTION

SUPER GENTLE & SOOTHING

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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