SPF30 CALENDULA SUNSCREEN- titanium dioxide lotion 
ORGANIC & SUSTAINABLE BEAUTY

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SPF30 CALENDULA™ SUNSCREEN LOTION

Drug Facts

Active ingredient

Titanium Dioxide 12%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only

Do not use: on damaged or broken skin.

Stop use and ask a doctor if

  • rash or irritation develops and lasts.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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.

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.

Principal Display Panel - 82 g Tube Label
SPF30 CALENDULA SUNSCREEN 
titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52915-067
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE120 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
isoamyl laurate (UNII: M1SLX00M3M)  
coco-caprylate (UNII: 4828G836N6)  
calendula officinalis flower (UNII: P0M7O4Y7YD)  
VIOLA TRICOLOR WHOLE (UNII: 9Q24RAI43V)  
polyglyceryl-2 dipolyhydroxystearate (UNII: 9229XJ4V12)  
CANDELILLA WAX (UNII: WL0328HX19)  
STARCH, RICE (UNII: 4DGK8B7I3S)  
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
levulinic acid (UNII: RYX5QG61EI)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
ROSEMARY (UNII: IJ67X351P9)  
COCONUT OIL (UNII: Q9L0O73W7L)  
squalane (UNII: GW89575KF9)  
magnesium stearate (UNII: 70097M6I30)  
p-anisic acid (UNII: 4SB6Y7DMM3)  
allantoin (UNII: 344S277G0Z)  
CLARY SAGE OIL (UNII: 87L0D4U3M0)  
TEA TREE OIL (UNII: VIF565UC2G)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)  
panthenol (UNII: WV9CM0O67Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52915-067-2982 g in 1 TUBE; Type 0: Not a Combination Product12/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35212/01/2012
Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)

Revised: 11/2020
Document Id: 82e0fcdf-5148-4e8f-8cd0-cc5ea347fa73
Set id: 64580be7-868c-40fb-b7b8-840b417b25d3
Version: 1
Effective Time: 20201106
 
ORGANIC & SUSTAINABLE BEAUTY