ZINCLEAR SPF 30 TINTED- zinc oxide cream

ZinClear SPF 30 Tinted by

Drug Labeling and Warnings

ZinClear SPF 30 Tinted by is a Otc medication manufactured, distributed, or labeled by Allure Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Zinc Oxide - 18.6%

PURPOSE

Purpose:Sunscreen

INDICATIONS & USAGE

Uses:

To help protect the skin from harmful UVA and UVB Rays

WARNINGS

Warnings:

For External Use only

WHEN USING

When using this product

• Keep out of eyes. If contact occurs, rinse with water
• Discontinue use if irritation or redness occurs

STOP USE

Stop use and ask a doctor

• if severe skin irritation develops

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

• if swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Directions

• Apply sunscreen in the AM to fingertips and gently massage into the skin. Reapply as needed
  

INACTIVE INGREDIENT

Inactive Ingredients:

Water (Aqua), Cyclopentasiloxane, Butylene Glycol, Glycerin, Caprylic/Capric Triglyceride, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxytethyl Dimethicone, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Caprylyl, Glycol, Ethylhexylglycerin, Hexylene Glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Xanthan Gum, Polyester-7, Neopentyl Glycol Diheptanoate, Tocopheryl Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycrrihizate, Arabidopsis THaliana Extract, Plankton Extract, Micrococcus Lysate, Triethoxycaprylysilane, Iron Oxides (CI77491, CI77492, CI77499)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ZINCLEAR SPF 30 TINTED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4064
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	186 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
TOCOPHEROL (UNII: R0ZB2556P8)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYESTER-7 (UNII: 0841698D2F)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
TEPRENONE (UNII: S8S8451A4O)
DATE (UNII: H3O7QI5HY7)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
SODIUM LACTATE (UNII: TU7HW0W0QT)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4064-2	1 in 1 CARTON
1	NDC: 62742-4064-1	56.7 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/22/2014

Labeler - Allure Labs Inc. (926831603)