THERMALAB DAILY BODY SPF30 BROAD SPECTRUM- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Thermalab by

Drug Labeling and Warnings

Thermalab by is a Otc medication manufactured, distributed, or labeled by Market Group New York LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone, 3.0 %

Homosalate, 10.0 %

Octisalate, 5.0 %

Octocrylene, 4.0 %

Oxybenzone, 4.0 %

PURPOSE

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Sunscreen

INDICATIONS & USAGE

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

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

-Apply liberally 15 minutes before sun exposure

-Reapply:  -after 40 minutes of swimming or sweating,

-immediately after towel drying,  -at least every 2 hours.

-Children under six 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 higherand 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

STORAGE AND HANDLING

Other Information  -protect the product in this

container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients  water, cyclopentasiloxane,

alcohol denat., propylene glycol, diethylhexyl

2,6-naphthalate, styrene/acrylates copolymer, acrylates

coplymer, silica, cetyl dimethicone, boron nitride,

phenoxyethanol, triethylene glycol, glyceryl stearate,

PEG-100 stearate, dimethicone, dimethicone/PEG-10/15

crosspolymer, potassium cetyl phosphate, fragrance,

sodium hydroxide, xanthan gum, carbomer, tocopheryl

acetate (vitamin E), panthenol (pro-vitamin B5),

acrylates/C10-13alkyl acrylate crosspolymer, allantoin,

disodium EDTA, BHT

QUESTIONS

Questions {or comments}?  (877) 266-6257

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERMALAB  DAILY BODY SPF30 BROAD SPECTRUM
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70080-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	4.5 g  in 150 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 150 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	7.5 g  in 150 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6 g  in 150 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 150 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
BORON NITRIDE (UNII: 2U4T60A6YD)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
DIMETHICONE (UNII: 92RU3N3Y1O)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ALLANTOIN (UNII: 344S277G0Z)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70080-001-01	7 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 70080-001-02	1 in 1 CARTON
2		150 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 not final	part352	08/15/2015

Labeler - Market Group New York LLC (079628339)