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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENTS:

OCTISALATE 5.0%

HOMOSALATE 5.0%

AVOBENZONE 3.0%

OCTOCRYLENE 2.7%

PURPOSE:

SUNSCREEN

USES

HELPS PREVENT SUNBURN

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. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

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 INFORMATION

QUESTIONS OR COMMENTS

CALL TOLL FREE 1-800-419-8783

NEW SPF 30 Facial Moisturizer

TRUE_Facial Moisturizer SPF 30_Carton_cropped

BEING TRUE ESSENTIALS ABSOLUTELY RADIANT 
octisalate, homosalate, avobenzone and octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60724-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60724-101-221 in 1 PACKAGE
1NDC:60724-101-1260 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/19/2013
Labeler - TRUE Cosmetics LLC (621646913)
Establishment
NameAddressID/FEIBusiness Operations
Northwest Cosmetic Laboratories LLC929572014manufacture(60724-101) , pack(60724-101)

Revised: 9/2013
Document Id: 67ff6112-769d-4b0f-919a-0a56e476fdd7
Set id: 7a154a0e-ad6e-42fd-8d72-4b385afa8a75
Version: 2
Effective Time: 20130919
 
TRUE Cosmetics LLC