ZINC FIVE-O SPF-50- zinc oxide lotion

ZINC FIVE-O by

Drug Labeling and Warnings

ZINC FIVE-O by is a Otc medication manufactured, distributed, or labeled by ASTIVITA LIMITED. 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 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINC FIVE-O  SPF-50
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80982-003
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 240 g

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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80982-003-39	240 g in 1 TUBE; Type 0: Not a Combination Product	11/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/20/2020

Labeler - ASTIVITA LIMITED (742799513)

Establishment
Name	Address	ID/FEI	Business Operations
ASTIVITA LIMITED		742799513	label(80982-003)