ZINC FIVE-O SPF-50- zinc oxide lotion 
ASTIVITA LIMITED

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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ZINC FIVE-O SPF-50

ACTIVE INGREDIENT

ZINC OXIDE 25%

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 ask doctor if rash occurs.

DIRECTIONS:

Apply liberally and evenly 15 minutes before sun exposure.

Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours 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 higher and 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
•Children under 6 months of age: ask a doctor.

OTHER INFORMATION

Store at temperatures below 90°F.

INACTIVE INGREDIENTS

Coco-caprylate/caprate, glycerine, coconut alkane, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3-polyricinoleate, cera alba (beeswax), isostearic acid, polyhydroxy stearic acid, maltodextrin, phenylpropanol, propanediol, caprylyl glycol, tocopherol, ethylhexylglycerin, cetyl phosphate, sodium chloride, disodium EDTA

01b LBL_Zinc Five-0_Sunscreen_SPF-50_Page_101b LBL_Zinc Five-0_Sunscreen_SPF-50_Page_2

ZINC FIVE-O  SPF-50
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80982-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 g  in 240 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
GLYCERIN (UNII: PDC6A3C0OX)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
JOJOBA OIL (UNII: 724GKU717M)  
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
PHENYLPROPANOL (UNII: 0F897O3O4M)  
PROPANEDIOL (UNII: 5965N8W85T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TOCOPHEROL (UNII: R0ZB2556P8)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80982-003-39240 g in 1 TUBE; Type 0: Not a Combination Product11/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/20/2020
Labeler - ASTIVITA LIMITED (742799513)
Establishment
NameAddressID/FEIBusiness Operations
ASTIVITA LIMITED742799513label(80982-003)

Revised: 1/2022
Document Id: d69e4b0d-d8be-911b-e053-2995a90aa50e
Set id: b318e85f-cec9-85d5-e053-2a95a90a6e3c
Version: 13
Effective Time: 20220127
 
ASTIVITA LIMITED