SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN- titanium dioxide stick

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 17%

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 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 30 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

Oleyl erucate, euphorbia cerifera (candelilla) wax, copernicia cerifera (carnauba) wax, caprylic/capric triglyceride, coco-caprylate, rosmarinus officinalis (rosemary) leaf extract, cymbopogon schoenanthus oil.

PRINCIPAL DISPLAY PANEL - 14 g Container Label

CALIFORNIA BABY®
trusted since 1995

everyday/year–round™
(gardenia & lemongrass)

BROAD SPECTRUM SPF 30+
SUNSCREEN STICK

WATER RESISTANT (80 MINUTES)
PHYSICAL BARRIER CONCENTRATED
TEAR FREE VEGAN
NO GLUTEN, SOY, OAT OR DAIRY

MINERAL BASED SUNSCREEN

ALLERGY
TESTED

for babies kids sensitive adults

Net Wt. 14 g / 0.5 Oz.

INGREDIENTS AND APPEARANCE

SPF30 EVERYDAY/YEAR-ROUND SUNSCREEN 
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52915-060
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	170 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Oleyl erucate (UNII: 753W099NQ6)
candelilla wax (UNII: WL0328HX19)
carnauba wax (UNII: R12CBM0EIZ)
medium-chain triglycerides (UNII: C9H2L21V7U)
coco-caprylate (UNII: 4828G836N6)
rosemary (UNII: IJ67X351P9)
cymbopogon schoenanthus oil (UNII: XE7K568ILO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52915-060-05	14 g in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	04/01/2011

Labeler - ORGANIC & SUSTAINABLE BEAUTY (020085717)