SHEERZINC SPF 30 TINTED - SUNKISSED- zinc oxide cream

SheerZinc SPF 30 Tinted - SunKissed by

Drug Labeling and Warnings

SheerZinc SPF 30 Tinted - SunKissed 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 developes

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:

• If swallowed, get medical help or contact a Poison Cpntrol center right away.

DOSAGE & ADMINISTRATION

Directions:

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

INACTIVE INGREDIENT

Other Ingredients: Water (Aqua), Cyclopentasiloxane, Butylene glycol, glycerin, Caprylic/Capric triglyceride, Glycerin Stearate, PEG-100 Stearate, Polyglyceryl-3 Polymethylsiloxyeethyl Dimethicon, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7,phenoxyethanol, Caprylyl Glycol, Ethylhexyglycerin, 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, tocopherol Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Triethoxycaprylysilane, Iron Oxides (CI77491, CI77492, CI77499) 

PRINCIPAL DISPLAY PANEL

Manufactured for DermaQuest, Inc.

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

INGREDIENTS AND APPEARANCE

SHEERZINC SPF 30 TINTED - SUNKISSED 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4094
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	186 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
DIMETHICONE (UNII: 92RU3N3Y1O)
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)
CARBOMER 1342 (UNII: 809Y72KV36)
CETYL ALCOHOL (UNII: 936JST6JCN)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
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)
.ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED)
TEPRENONE (UNII: S8S8451A4O)
DATE (UNII: H3O7QI5HY7)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
SODIUM LACTATE (UNII: TU7HW0W0QT)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)
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: 62742-4094-2	1 in 1 CARTON	12/01/2017
1	NDC: 62742-4094-1	56.7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/28/2017

Labeler - Allure Labs Inc (926831603)

Registrant - Allure Labs Inc (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs Inc		926831603	manufacture(62742-4094)