DAILY SPF PRIMER SPF 50- zinc oxide lotion 
Lee Indie & Co Inc

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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INDIE LEE - DAILY SPF PRIMER SPF 50 (81545-102)

ACTIVE INGREDIENT

ZINC OXIDE 12%

PURPOSE

SUNSCREEN

USES

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 CONSULT A PHYSICIAN IF RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

INACTIVE INGREDIENTS

Water, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Jojoba Esters, Propanediol, Tridecyl Salicylate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Methylheptyl Isostearate, Niacinamide, Nylon-12, Methylpropanediol, Silica, Coco-Caprylate, Allantoin, Bisabolol, Oryza Sativa (Rice) Bran Extract, Helianthus Annuus (Sunflower) Extract, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Chloride, Polyglyceryl-2 Dipolyhydroxystearate, Caprylyl Glycol, Lecithin, Phenylpropanol, Tetrasodium Glutamate Diacetate, Hydrogenated Lecithin, Sodium Hydroxide, CI 77491, CI77492, CI 77499 (Iron Oxides)

OTHER INFORMATION

Protect this product from excessive heat and direct sun. Store below 90°F (32°C).

QUESTIONS OR COMMENTS?

1 (866) 488-1638 MON-FRI (9 A.M. - 5 P.M. EST)

unit_carton

DAILY SPF PRIMER  SPF 50
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81545-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 64-70) (UNII: 96YYQ5TK1K)  
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
PROPANEDIOL (UNII: 5965N8W85T)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
METHYLHEPTYL ISOSTEARATE (UNII: 981F40Q9FF)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
NYLON-12 (UNII: 446U8J075B)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
COCO-CAPRYLATE (UNII: 4828G836N6)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ALLANTOIN (UNII: 344S277G0Z)  
LEVOMENOL (UNII: 24WE03BX2T)  
RICE BRAN (UNII: R60QEP13IC)  
HELIANTHUS ANNUUS WHOLE (UNII: 17S27ZT6KR)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ROSEMARY (UNII: IJ67X351P9)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81545-102-401 in 1 BOX09/17/2021
140 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2021
Labeler - Lee Indie & Co Inc (117191089)

Revised: 1/2023
Document Id: eb070c0e-d7f0-f554-e053-2995a90a392b
Set id: eb070c0e-d7f1-f554-e053-2995a90a392b
Version: 1
Effective Time: 20230106
 
Lee Indie & Co Inc