BROAD SPECTRUM FACE AND BODY SUNSCREEN STICK SPF 30- zinc oxide stick

Broad Spectrum Face and Body Sunscreen Stick SPF 30 by

Drug Labeling and Warnings

Broad Spectrum Face and Body Sunscreen Stick SPF 30 by is a Otc medication manufactured, distributed, or labeled by Ct Organics Llc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Zinc oxide 20%

Purpose

sunscreen

KEEP OUT OF REACH OF CHILDREN

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

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see directions) decreases the risk of skin cancer and early skin aging by the sun

Warnings

For external use only

Do not use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

Directions

• apply liberally 15 minutes before sun exposure
• reapply:

     after 45 minutes of swimming or sweating
     immediately after towel drying
     at least every two hours

• 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 of 15 or higher and other sun protection measure including:

     limit time in the sun, especially from 10 a.m. – 2 p.m. 
     wear long-sleeve shirts, pants, hats, and sunglasses 

• children under 6 months: Ask a doctor

Inactive ingredients

organic coconut oil, beeswax, wheat germ oil, organic olive oil, organic shea butter, geranium essential oil, astaxanthin

Other information

• protect this product from excessive heat and direct sun

Questions or comments

Visit our website www.ctorganics.com to contact us

SPL UNCLASSIFIED SECTION

Free of

nano and micronized zinc oxide

parabens

fragrances

Incase of any allergies stop using and contact your physician.

Packaging

INGREDIENTS AND APPEARANCE

BROAD SPECTRUM FACE AND BODY SUNSCREEN STICK SPF 30 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70580-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
YELLOW WAX (UNII: 2ZA36H0S2V)
WHEAT GERM OIL (UNII: 14C97E680P)
OLIVE OIL (UNII: 6UYK2W1W1E)
SHEA BUTTER (UNII: K49155WL9Y)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70580-101-95	95 g in 1 BOTTLE; Type 0: Not a Combination Product	04/05/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/05/2016

Labeler - Ct Organics Llc (066143076)

Establishment
Name	Address	ID/FEI	Business Operations
Ct Organics Llc		066143076	manufacture(70580-101)