SPF30 CALENDULA SUNSCREEN- titanium dioxide lotion

SPF30 CALENDULA SUNSCREEN by

Drug Labeling and Warnings

SPF30 CALENDULA SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by ORGANIC & SUSTAINABLE BEAUTY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Titanium Dioxide 12%

Purpose

Sunscreen

Uses

Helps prevent sunburn

• higher SPF gives more sunburn protection
• retains SPF after 80 minutes of activity in the water

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

• 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.

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.

INGREDIENTS AND APPEARANCE

SPF30 CALENDULA SUNSCREEN 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52915-067
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	120 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52915-067-29	82 g in 1 TUBE; Type 0: Not a Combination Product	12/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/01/2012

Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)