BEING TRUE ESSENTIALS ABSOLUTELY RADIANT- octisalate, homosalate, avobenzone and octocrylene lotion

BEING TRUE ESSENTIALS ABSOLUTELY RADIANT by

Drug Labeling and Warnings

BEING TRUE ESSENTIALS ABSOLUTELY RADIANT by is a Otc medication manufactured, distributed, or labeled by TRUE Cosmetics LLC, Northwest Cosmetic Laboratories LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:

OCTISALATE 5.0%

HOMOSALATE 5.0%

AVOBENZONE 3.0%

OCTOCRYLENE 2.7%

PURPOSE

PURPOSE:

SUNSCREEN

INDICATIONS & USAGE

USES

HELPS PREVENT SUNBURN

WARNINGS

WARNINGS

SKN CANCER/SKIN AGING ALERT: SPENDING TIME IN THE SUN INCREASES YOU RISK OF SKIN CANCER AND EARLY SKIN AGING. THIS PRODUCT HAS BEEN SHOWN ONLY TO PREVENT SUNBURN, NOT SKIN CANCER OR EARLY AGING.

FOR EXTERNAL USE ONY.

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
• USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING
• REAPPLY AT LEAST EVERY 2 HOURS
• ASK A DOCTOR FOR CHILDREN UNDER 6 MONTHS

INACTIVE INGREDIENT

INACTIVE INGREDENTS

ALOE BARBADENSIS LEAF JUICE, ALOE BARBADENSIS LEAF EXTRACT, AMINOMETHYL PROPANOL, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CETEARYL ALCOHOL, CHLORPHENESIN, CITRUS SINENSIS (BLOOD ORANGE) FRUIT EXTRACT, COCO CAPRYLATE/CAPRATE, DECYL GLUCOSIDE, DEXTRIN, DIMETHICONE, DISODIUM EDTA, ETHYHEXYL STEARATE, HYDROLYZED HIBISCUS ESCULENTUS EXTRACT, ISODODECANE, PEG-100 STEARATE, PENTYLENE GLYCOL, PHENOXYETHANOL, POLYSILICONE-11, POLYURETHANE-34, SODIUM CITRATE, SODIUM POLYACRYLATE, TAPIOCA STARCH, POLYMETHYLSILSESQUIOXANE, TOCOPHERYL ACETATE, TRIDECETH 6, WATER, XANTHAN GUM.

OTHER SAFETY INFORMATION

OTHER INFORMATION

• PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

QUESTIONS

QUESTIONS OR COMMENTS

CALL TOLL FREE 1-800-419-8783

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BEING TRUE ESSENTIALS ABSOLUTELY RADIANT 
octisalate, homosalate, avobenzone and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60724-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CHLORPHENESIN (UNII: I670DAL4SZ)
CITRUS SINENSIS WHOLE (UNII: 37673443KL)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ICODEXTRIN (UNII: 2NX48Z0A9G)
PEG-100 STEARATE (UNII: YD01N1999R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSILICONE-15 (UNII: F8DRP5BB29)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
STARCH, TAPIOCA (UNII: 24SC3U704I)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60724-101-22	1 in 1 PACKAGE
1	NDC: 60724-101-12	60 mL in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/19/2013

Labeler - TRUE Cosmetics LLC (621646913)

Establishment
Name	Address	ID/FEI	Business Operations
Northwest Cosmetic Laboratories LLC		929572014	manufacture(60724-101) , pack(60724-101)