ZINC FIVE-O ZINXATION BABY MINERAL SUNSCREEN 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.

----------

ZINC FIVE-O ZINXATION BABY MINERAL SUNSCREEN 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 A DOCTOR IF RASH OCCURS.

DIRECTIONS:

OTHER INFORMATION

STORE AT TEMPERATURES BELOW 90°F (30°C). PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS

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

QUESTIONS?

contactbaby@zincfive0.com

01b LBL_ZINC FIVE-0 BABY FDA_front

01b LBL_ZINC FIVE-0 BABY FDA_back

ZINC FIVE-O ZINXATION BABY MINERAL SUNSCREEN  SPF-50
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80982-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 g  in 120 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)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
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:80982-005-37120 g in 1 TUBE; Type 0: Not a Combination Product11/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/02/2020
Labeler - ASTIVITA LIMITED (742799513)
Establishment
NameAddressID/FEIBusiness Operations
ASTIVITA LIMITED742799513label(80982-005)

Revised: 1/2022
Document Id: d69e45bc-c101-6d05-e053-2a95a90a6543
Set id: b3199cf4-eb90-68c2-e053-2a95a90a8a29
Version: 7
Effective Time: 20220127
 
ASTIVITA LIMITED