NON-NANO SUNSCREEN SPF 40- zinc oxide lotion 
ProCaps Laboratories, 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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Solé non-nano zinc oxide SPF 40 sunscreen

ACTIVE INGREDIENT

Zinc Oxide 17.5%

PURPOSE

Sunscreen

USE

DIRECTIONS

OTHER INFORMATION

QUESTIONS?

CALL 800.800.1200
www.ProCapsLabs.com

INACTIVE INGREDIENTS

Water (Aqua), Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Seed Oil, Cetearyl Alcohol, Silica, Coco-Glucoside, Microcrystalline Cellulose, Glycerin, Pyrus Malus (Apple) Fruit Extract, Cocoyl Proline, Humulus Lupulus (Hops) Extract, Isostearic Acid, Phenylpropanol, Polyhydroxystearic Acid, Xanthan Gum

606114-01U Sole_Box_6oz_MOCKUPwDIELINE

NON-NANO SUNSCREEN  SPF 40
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72879-505
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION17.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
JOJOBA OIL (UNII: 724GKU717M)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
COCO-GLYCERIDES (UNII: ISE9I7DNUG)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
GLYCERIN (UNII: PDC6A3C0OX)  
APPLE (UNII: B423VGH5S9)  
COCOYL PROLINE (UNII: 0IH06971TF)  
HOPS (UNII: 01G73H6H83)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72879-505-021 in 1 BOX03/29/2019
159 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:72879-505-041 in 1 BOX03/29/2019
2118 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:72879-505-061 in 1 BOX03/29/2019
3177 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/29/2019
Labeler - ProCaps Laboratories, Inc. (144872652)
Establishment
NameAddressID/FEIBusiness Operations
Thibiant International, Inc.083913913manufacture(72879-505)

Revised: 2/2019
Document Id: 3de0ebf2-5cda-43a1-8972-0ec16379b75c
Set id: 6f55b142-e726-400a-ab4f-59630b49208f
Version: 2
Effective Time: 20190227
 
ProCaps Laboratories, Inc.