SOLBAR ZINC SPF38 cream

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

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Active ingredient:
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)
Available from:
Person and Covey
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Helps prevent sunburn. Sunscreen
Authorization status:
OTC monograph final
Authorization number:
0096-0688-04

SOLBAR ZINC SPF38- solbar zinc spf38 cream

Person and Covey

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.

----------

Solbar Zinc

Indications and use

Helps prevent sunburn.

Purpos e

Sunscreen

Keep out of the reach of children

Yes. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage and Administration

Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure.

Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least

every 2 hours. For children under 6 months, ask a physician.

Warnings

For external use only. Do not use on damaged or broken skin. Keep out of eyes. Rinse eyes thoroughly

with water to remove. Stop use and ask a physician if rash or irritation develops and lasts. Store away

from excessive heat and direct sun.

OTC - ACTIVE INGREDIENT SECTION

Homosalate

Octinoxate

Zinc Oxide

INACTIVE INGREDIENT SECTION

Water

Isobutyl Stearate

PEG-100 Stearate

Glycerin

Dimethicone

PVP/Eicosene Copolymer

Glyceryl Dilaurate

Cetyl Alcohol

DEA Cetyl Phosphate

Benzyl Alcohol

Cyclomethicone

Stearyl Alcohol

Xanthan Gum

Disodium EDTA

Citric Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Solbar Zinc.jpg

SOLBAR ZINC SPF38

solbar zinc spf38 cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 0 9 6 -0 6 8 8

Route of Administration

TOPICAL

Person and Covey

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

0 .10 15 in 1 g

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

0 .0 77 in 1 g

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

ZINC CATION

0 .0 77 in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ISO BUTYL STEARATE (UNII: V8 DPR6 HNX3)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

GLYCERIN (UNII: PDC6 A3C0 OX)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

EICO SYL PO VIDO NE ( 2 EICO SYL BRANCHES/REPEAT) (UNII: XQQ9 MKE2BJ)

GLYCERYL DILAURATE (UNII: MFL3ZIE8 SK)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

DIETHANO LAMINE CETYL PHO SPHATE (UNII: 4UG0 316 V9 S)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

CYCLO METHICO NE (UNII: NMQ3479 9 4Z)

STEARYL ALCO HO L (UNII: 2KR8 9 I4H1Y)

XANTHAN GUM (UNII: TTV12P4NEE)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 0 9 6 -0 6 8 8 -0 4

115 g in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 6 /0 1/19 9 6

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt352

0 6 /0 1/19 9 6

Labeler -

Person and Covey (008482473)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Perso n and Co vey

0 0 8 48 2473

ma nufa c ture (0 0 9 6 -0 6 8 8 )

Revised: 1/2020

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