THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM DARK- octinoxate, octisalate, avobenzone cream

the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum dark by

Drug Labeling and Warnings

the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum dark by is a Otc medication manufactured, distributed, or labeled by Columbia Cosmetics Manufacturing, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum dark

Active ingredients:

OCTINOXATE (7.5%)
OCTISALATE (3.0%)
AVOBENZONE (3.0%)

Purpose

Sunscreen

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 caused by the sun.
  

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
• use a water resistant sunscreen if swimming or sweating
• reapply 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 AM - 2 PM.
  
• wear long-sleeved shirts, pants, hats and sunglasses

Inactive ingredients:

• WATER (AQUA) - CETEARYL ALCOHOL - lSOPROPYL MYRISTATE - CETYL DIMETHICONE - DIMETHICONE - HEXYL LAURATE - POTASSIUM CETYL PHOSPHATE - HYDROXYETHYL ACRYLATE-SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER - lSOHEXADECANE - POLYSORBATE 60 - STYRENE-DVB CROSSPOLYMER - SORBITAN SESQUIOLEATE - PHENOXYETHANOL - CAPRYLYL GLYCOL - ETHYLHEXYL GLYCERIN - HEXYLENE GLYCOL - SODIUM DEHYDROACETATE MAY CONTAIN: TITANIUM DIOXIDE CI 77891 - IRON OXIDES CI 77491 - CI 77492 - CI 77499

Other information:

• protect this product from excessive heat and direct sun
  

the Balm cosmetics SPF 18

Balm Shelter the Balm tinted moisturizer SPF 18 - hydratant

Designed for all skin types. This weightless silky smooth tinted moisturizer SPF 18 offers lasting moisture and helps to improve the tone and texture of your skin, leaving you with a polished complexion. Apply to clean face.

Please recycle this box.  24 M

the Balm - San Francisco, CA 94123, USA www.theBalm.com
theBalm's (Cosmetics) LTD 64 Sutton Park, Sutton, Dublin 13 Ireland
Made in the USA.

Sun Protection for Everyday Drama

PRINCIPAL DISPLAY PANEL

Balm Shelter tinted moisturizer SPF 18 broad spectrum the Balm

64 mL e 2.15 FL. OZ. US

the Balm BalmShelter tinted moisturizer SPF 18 broad spectrum dark 64ml (

61016-0006-0)

INGREDIENTS AND APPEARANCE

THE BALM BALMSHELTER TINTED MOISTURIZER SPF 18 BROAD SPECTRUM DARK 
octinoxate, octisalate, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61016-0006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
DIMETHICONE (UNII: 92RU3N3Y1O)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STYRENE (UNII: 44LJ2U959V)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61016-0006-0	1 in 1 CARTON	07/29/2013
1		64 mL 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 not final	part352	07/29/2013

Labeler - Columbia Cosmetics Manufacturing, Inc. (068267863)

Establishment
Name	Address	ID/FEI	Business Operations
Columbia Cosmetics Manufacturing, Inc.		068267863	manufacture(61016-0006)