SHEER MINERAL SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide cream

Sheer Mineral Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Sheer Mineral Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients:

Zinc Oxide 18.6%

PURPOSE

Purpose: Sunscreen

INDICATIONS & USAGE

Uses helps to prevent sunburn

if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

Warnings For external use only

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product keep out of eyes. Rinse with warm water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help, or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions Apply liberally 15 minutes before sun exposure.

Children under 6 months: Ask a doctor

Reapply: 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 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-sleeve shirts, pants, hats, and sunglasses.

OTHER SAFETY INFORMATION

Other information Protect this product from excessive heat or direct sun.

INACTIVE INGREDIENT

Inactive Ingredients:

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SHEER MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4242
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	18.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
TRIETHOXYSILYLETHYL POLYDIMETHYLSILOXYETHYL HEXYL DIMETHICONE (UNII: X75PL53TZJ)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ARABIDOPSIS THALIANA (UNII: AI3L60HQ81)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
DIMETHICONE (UNII: 92RU3N3Y1O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DATE (UNII: H3O7QI5HY7)
POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
TEPRENONE (UNII: S8S8451A4O)
POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-100 STEARATE (UNII: YD01N1999R)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH)
LAURETH-7 (UNII: Z95S6G8201)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM LACTATE, L- (UNII: P2Y1C6M9PS)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
MICROCOCCUS LUTEUS (UNII: LV6L29Z6AX)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
ASCORBIC ACID (UNII: PQ6CK8PD0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4242-1	56.7 g in 1 TUBE; Type 0: Not a Combination Product	12/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/13/2023

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4242)