ZINC FIVE-O ZINXATION KIDS SUNSCREEN SPF-50- zinc oxide lotion

ZINC FIVE-O ZINXATION KIDS SUNSCREEN by

Drug Labeling and Warnings

ZINC FIVE-O ZINXATION KIDS SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by ANTARIA PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ZINC OXIDE 25%

PURPOSE

SUNSCREEN

USES

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreased the risk of skin cancer and early skin aging caused by the sun

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:

• APPLY LIBERALLY AND EVENLY 20 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 (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,  phenylpropanol, propanediol, caprylyl glycol, tocopherol, ethylhexylglycerin, cetyl phosphate, sodium chloride, disodium EDTA, Vanilla Planifolia Bean Extract

QUESTIONS?

contactkids@zincfive0.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC FIVE-O ZINXATION KIDS SUNSCREEN  SPF-50
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60396-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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)
VANILLA BEAN (UNII: Q74T35078H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60396-210-11	200 mL in 1 TUBE; Type 0: Not a Combination Product	05/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/24/2020

Labeler - ANTARIA PTY LTD (740611405)

Establishment
Name	Address	ID/FEI	Business Operations
ANTARIA PTY LTD		740611405	manufacture(60396-210)