SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN- titanium dioxide lotion/shampoo

SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN by

Drug Labeling and Warnings

SPF30 EVERYDAY/YEAR-ROUND 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 occurs.

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: 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, 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, gardenia tahitensis flower extract, squalane, magnesium stearate, p-anisic acid, cymbopogon schoenanthus oil, allantoin, panthenol.

PRINCIPAL DISPLAY PANEL - 82 g Tube Label

CALIF♥RNIA BABY®
trusted since 1995

everyday/year–round™

BROAD SPECTRUM
SPF 30+ SUNSCREEN
WATER RESISTANT (80 MINUTES)

GARDENIA & LEMONGRASS VEGAN TEAR FREE
PHYSICAL BARRIER CONCENTRATED
NO GLUTEN, SOY, OAT OR DAIRY

MINERAL–BASED
FACE & BODY

ALLERGY
TESTED

for babies kids
sensitive adults

Net Wt. 82 g/2.9 Oz.

INGREDIENTS AND APPEARANCE

SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN 
titanium dioxide lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52915-030
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 (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)
panthenol (UNII: WV9CM0O67Z)
gardenia taitensis flower (UNII: T0OCU8201Y)
cymbopogon schoenanthus oil (UNII: XE7K568ILO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52915-030-29	82 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/31/2015

Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)