ZINC FIVE-O SPF-50- zinc oxide lotion

United States - English - NLM (National Library of Medicine)

Buy It Now

Active ingredient:
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Available from:
ANTARIA PTY LTD
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
SUNSCREEN - 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
Authorization status:
OTC monograph not final
Authorization number:
60396-202-12

ZINC FIVE-O SPF-50- zinc oxide lotion

ANTARIA PTY LTD

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 SPF-50

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

ZINC FIVE-O SPF-50

zinc oxide lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 0 39 6 -20 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8 SF37)

ZINC CATION

25 g in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

CO CO -CAPRYLATE/CAPRATE (UNII: 8 D9 H4QU9 9 H)

GLYCERIN (UNII: PDC6 A3C0 OX)

CO CO NUT ALKANES (UNII: 1E5KJY10 7T)

JO JO BA O IL (UNII: 724GKU717M)

PO LYGLYCERYL-3 RICINO LEATE (UNII: MZQ6 3P0 N0 W)

YELLO W WAX (UNII: 2ZA36 H0 S2V)

ISO STEARIC ACID (UNII: X33R8 U0 0 6 2)

PO LYHYDRO XYSTEARIC ACID ( 2 3 0 0 MW) (UNII: YXH47AOU0 F)

MALTO DEXTRIN (UNII: 7CVR7L4A2D)

PHENYLPRO PANO L (UNII: 0 F8 9 7O3O4M)

PRO PANEDIO L (UNII: 59 6 5N8 W8 5T)

CAPRYLYL GLYCO L (UNII: 0 0 YIU5438 U)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

CETYL PHO SPHATE (UNII: VT0 7D6 X6 7O)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 0 39 6 -20 2-12

20 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 5/26 /20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 5/26 /20 19

ANTARIA PTY LTD

Labeler -

ANT ARIA PT Y LT D (743874997)

Revised: 6/2020

Similar products

Search alerts related to this product

View documents history

Share this information