REJUVENATING PRIMING MOISTURIZER BS SUNSCREEN SPF30- zinc oxide cream

Rejuvenating Priming Moisturizer BS Sunscreen SPF30 by

Drug Labeling and Warnings

Rejuvenating Priming Moisturizer BS Sunscreen SPF30 by is a Otc medication manufactured, distributed, or labeled by Allure Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Zinc Oxide 16%

PURPOSE

Purpose Sunscreen

INDICATIONS & USAGE

Use(s) helps 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 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 and evenly to face 15 minutes before sun exposure use a water-resistant sunscreen if swimming or sweating reapply 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, hat and sunglasses children under 6 months: Ask a doctor

OTHER SAFETY INFORMATION

Other Information Protect this product from excessive heat & direct sun.

INACTIVE INGREDIENT

Inactive Ingredients: Water, Brassica Napus Extract, Dimethicone, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Glycerin, Propanediol, Bentonite, Cetearyl Alcohol, Polyglyceryl-8 Oleate, Sodium Chloride, Peptide-Rich Plasma® (sh-Oligopeptide-2, sh-Polypeptide-1, sh-Polypeptide-9, sh-Polypeptide-11, Acetyl Hexapeptide-8, sh-Oligopeptide-1, Palmitoyl Tripeptide-5, Palmitoyl Tetrapeptide-7, Acetyl Glutamine, Sodium Hyaluronate, Lysine HCL, Alanine, Histidine HCL, Arginine, Serine, Proline, Glutamic Acid, Threonine, Valine, Leucine, Glycine, Isoleucine, Phenylalanine, Taurine), Lactic Acid, Honey, Dimethylmethoxy Chromanyl Palmitate, Hydrolyzed Sodium Hyaluronate, Allantoin, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Bacillus/Folic Acid Ferment Filtrate Extract, Lecithin, Butylene Glycol, Maltodextrin, Mannitol, Xanthan Gum, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Glycol, Citric Acid, Polysorbate 20, 1,2-Hexanediol, Polyhydroxystearic Acid, Phenoxyethanol, Ehtylhexylglycerin, Iron Oxides, Mica.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

REJUVENATING PRIMING MOISTURIZER BS SUNSCREEN SPF30 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62742-4258
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	16 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
GLUTAMIC ACID (UNII: 3KX376GY7L)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
BRASSICA NAPUS WHOLE (UNII: NFP6814VZ4)
HISTIDINE MONOHYDROCHLORIDE (UNII: 1D5Q932XM6)
PROLINE (UNII: 9DLQ4CIU6V)
PHENYLALANINE (UNII: 47E5O17Y3R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ALLANTOIN (UNII: 344S277G0Z)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
XANTHAN GUM (UNII: TTV12P4NEE)
BENTONITE (UNII: A3N5ZCN45C)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MECASERMIN (UNII: 7GR9I2683O)
NEPIDERMIN (UNII: TZK30RF92W)
DIMETHICONE (UNII: 92RU3N3Y1O)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
ALANINE (UNII: OF5P57N2ZX)
TAURINE (UNII: 1EQV5MLY3D)
LACTIC ACID (UNII: 33X04XA5AT)
HONEY (UNII: Y9H1V576FH)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
SERINE (UNII: 452VLY9402)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MANNITOL (UNII: 3OWL53L36A)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
THREONINE (UNII: 2ZD004190S)
ISOLEUCINE (UNII: 04Y7590D77)
FOLIC ACID (UNII: 935E97BOY8)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
FIBROBLAST GROWTH FACTOR-1 (UNII: G53298VN9Y)
GLYCINE (UNII: TE7660XO1C)
CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
BASIC FIBROBLAST GROWTH FACTOR (HUMAN) (UNII: S3529G9M9V)
ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
ACEGLUTAMIDE (UNII: 01J18G9G97)
LEUCINE (UNII: GMW67QNF9C)
WATER (UNII: 059QF0KO0R)
HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
MICA (UNII: V8A1AW0880)
LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
ARGININE (UNII: 94ZLA3W45F)
VALINE (UNII: HG18B9YRS7)
DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62742-4258-2	1 in 1 CARTON	03/29/2024
1	NDC: 62742-4258-1	30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/29/2024

Labeler - Allure Labs (926831603)

Registrant - Allure Labs (926831603)

Establishment
Name	Address	ID/FEI	Business Operations
Allure Labs		926831603	manufacture(62742-4258)