MINERAL SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF 20- zinc oxide and titanium dioxide cream

Mineral Sunscreen Moisturizer Broad Spectrum SPF 20 by

Drug Labeling and Warnings

Mineral Sunscreen Moisturizer Broad Spectrum SPF 20 by is a Otc medication manufactured, distributed, or labeled by Allure Labs, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide - 4.80%

Zinc Oxide - 5.00%

INDICATIONS & USAGE

Helps prevent sunburn

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

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 water to remove.

STOP USE

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH OF CHILDREN

if product is swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

apply liberally 15 minutes before sun exposure.

use a water resistant sunscreen if swimming or sweating.

reapply:

immidiately aftr swimming, sweating or towel drying.

at least every 2 hours.

children under 6months: ask doctor

Sun protection measures:

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protector measures including:

limit time in the sun, especially from 10:00 am to 2:00 pm.

wear long sleaved shirts, pants, hats and sun glasses.

OTHER SAFETY INFORMATION

May stain or damage some fabrics or surfaces. Avoid long term storage above 40C (120F). Protect the product in this container from excessive heat and direct sunlight.

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglyceride, Ethylhexyl Palmitate, Glycerin, Cetearyl Alcohol, Cetyl Alcohol, Polyhydroxysteari Acid, Vitis Vinifera (Grape) Seed Oil, Sodium Stearoyl Glutamate, Glyceryl Stearate, Cetearyl Glucoside, Sorbitan Stearate, Tetrahexyldecyl Ascorbate, Pichia/Resveratrol Ferment Extract, Malus Domestica Fruit Cell Culture Extract, Simmondsia Chinesis (Jojoba) Seed Oil, Sodium Hyaluronate, Carrageenan, Glucose, Tocopherol, Myristoyl Pentapeptide-11, Bisabolol, Benzylidene Dimethoxydimethylindanone, Tetrahydrodiferuloylmethane, Glyceryl Isostearate, Water (Aqua), Aluminum Stearate, Alumina, Microcrystalline Cellulose, Cellulose Gum, Phenoxyethanol, Xanthan Gum, Ethylhexylglycerin, Caprylyl Glycol, Lecithin, Citric Acid, Disodium EDTA, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Mentha Viridis (Spearmint) Leaf Oil, Fusanus Spicatus Wood Oil, Salvia Sclarea (Clary) Oil, Rosa Damascena Flower Oil, Mentha Piperita (Peppermint) Oil, Citrus Reticulata (Tangerine) Leaf Oil, Pogostemon Cablin Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Myristica Fragrans (Nutmeg) Kernel Oil, Commiphora Myrrha Oil, Citrus Aurantifolia (Lime) Oil, Citrus Limon (Lemon) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Citrus Grandis (Grapefruit) Peel Oil, Abies Sibirica Oil, Eucalyptus Globulus Leaf Oil, Juniperus Virginiana Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Extract, Citrus Nobilis (Mandarin Orange) Peel Oil, Pelargonium Graveolens Flower Oil, Ferula Galbaniflua (Galbanum) Resin Oil, Triethyl Citrate, Vanillin, Ethyl Vanillin, Limonene, Linalool, Benzyl Alcohol, Feraniol, Citronellol.

PRINCIPAL DISPLAY PANEL

Distributed By:

The Soleil Group, LLC.

Bronxville, NY 10708

Energie 43

1271 EC Huizen, Netherlands

www.soleiltoujours.com

MADE IN U.S.A.

INGREDIENTS AND APPEARANCE

MINERAL SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF 20 
zinc oxide and titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4153
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	50.0 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	48.0 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE (UNII: V5VD430YW9)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CETYL ALCOHOL (UNII: 936JST6JCN)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
MALUS DOMESTICA FLOWER (UNII: EF626V855K)
SIMMONDSIA CHINENSIS SEED (UNII: D24K2Q1F6H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CARRAGEENAN (UNII: 5C69YCD2YJ)
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)
BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)
TETRAHYDRODIFERULOYLMETHANE (UNII: 00U0645U03)
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)
WATER (UNII: 059QF0KO0R)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
ALUMINUM OXIDE (UNII: LMI26O6933)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
THYMUS VULGARIS LEAF (UNII: GRX3499643)
SPEARMINT OIL (UNII: C3M81465G5)
SANTALUM SPICATUM OIL (UNII: H9LVS6REV4)
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
PEPPERMINT OIL (UNII: AV092KU4JH)
CITRUS RETICULATA LEAF OIL (UNII: 1515UE78IH)
PATCHOULI OIL (UNII: F3IN55X5PO)
ORANGE PEEL (UNII: TI9T76XD44)
NUTMEG OIL (UNII: Z1CLM48948)
MYRRH OIL (UNII: H74221J5J4)
LIME OIL (UNII: UZH29XGA8G)
LEMON OIL (UNII: I9GRO824LL)
LAVENDER OIL (UNII: ZBP1YXW0H8)
GRAPEFRUIT PEEL (UNII: 3582N05Q44)
ABIES SIBIRICA LEAF OIL (UNII: XRY0V4VZKZ)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
JUNIPERUS VIRGINIANA OIL (UNII: PAD4FN7P2G)
BERGAMOT OIL (UNII: 39W1PKE3JI)
MANDARIN OIL (UNII: NJO720F72R)
GALBANUM OIL (UNII: 211UF7M8N1)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
VANILLIN (UNII: CHI530446X)
ETHYL VANILLIN (UNII: YC9ST449YJ)
LIMONENE OXIDE, (+)- (UNII: 278IM94GXB)
LINALOOL, (+)- (UNII: F4VNO44C09)
BENZYL ALCOHOL (UNII: LKG8494WBH)
GERANIOL (UNII: L837108USY)
CITRONELLOL ACETATE, (R)- (UNII: 9X45FJL446)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4153-2	1 in 1 CARTON	12/12/2017
1	NDC: 62742-4153-1	40 mL in 1 BOTTLE; 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	12/12/2017

Labeler - Allure Labs, Inc (926831603)

Registrant - Allure Labs, Inc (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs, Inc		926831603	manufacture(62742-4153)