BEAUTIFUL SKIN SUPERFLUID BROAD SPECTRUM SPF30 M1- zinc oxide emulsion

Beautiful Skin Superfluid Broad Spectrum SPF30 M1 by

Drug Labeling and Warnings

Beautiful Skin Superfluid Broad Spectrum SPF30 M1 by is a Otc medication manufactured, distributed, or labeled by Rationale Group Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 16.9%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun.

Warnings

For external use only. 

Do not use

• On damaged or broken skin.

When using this product

Keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

Rash occurs.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DirectionsMM

• Apply liberally 15 minutes before sun exposure.
• Reapply 
• At least every 2 hours
• Use a water resistant sunscreen if swimming or sweating.
• Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
• Limit time in the sun, especially from 10 a.m.- 2p.m.
• Wear long sleeved shirts, pants, hats and sunglasses.
• Children under 6 months of age: Ask a doctor.

Other Information

• Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

Undecane, Aqua (Water), Coco-Caprylate, Caprylic/Capric Triglyceride, Tridecane, Butyloctyl Salicylate, Lauryl PEG-10 Tris (Trimethylsiloxy) silylethyl Dimethicone, Polyhydroxystearic Acid, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Triacontanyl PVP, Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Pentylene Glycol, Ethylhexyl Methoxycrylene, Sodium Palmitoyl Proline, Propanediol, CI 77891 (Titanium Dioxide), Silica, Butylene Glycol, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Boron Nitride, Sodium Chloride, Polyurethane-79, Polyurethane-62, Isopropyl Palmitate, Mica, Bisabolol, 1,2-Hexanediol, Sodium Potassium Aluminum Silicate, Limonene, Panthenol, Lecithin, Tocopherol, C12-15 Alkyl Benzoate, Citrus Aurantium Dulcis (Orange) Oil, Caprylhydroxamic Acid, Trideceth-10, CI 77492 (Iron Oxides), Tin Oxide, Citrus Aurantium Bergamia (Bergamot) Leaf Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Oil, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Ceteareth-25, Helianthus Annuus (Sunflower) Seed Oil, Melanin, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Litsea Cubeba Fruit Oil, Citral, CI 77491 (Iron Oxides), Glycerin, Cetyl Alcohol, CI 77499 (Iron Oxides), Triethoxycaprylylsilane, Magnesium Aspartate, Zinc Gluconate, Nymphaea Alba Flower Extract, Linalool, Cyclopentasiloxane, Glycine, Behenic Acid, Ceramide NP, Cholesterol, Ceramide NS, Serine, Glutamic Acid, PEG/PPG-18/18 Dimethicone, Aspartic Acid, Leucine, Ethylhexylglycerin, Ceramide AP, Ceramide EOP, Ceramide EOS, Copper Gluconate, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Proline, Threonine, Valine, Isoleucine, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Phenoxyethanol, Sodium Hyaluronate, Histidine, Acetyl Hexapeptide-1.

Package Labeling:30ml

Package Labeling:3ml

INGREDIENTS AND APPEARANCE

BEAUTIFUL SKIN SUPERFLUID BROAD SPECTRUM SPF30 M1 
zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83108-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	169 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRAL (UNII: T7EU0O9VPP)
UNDECANE (UNII: JV0QT00NUE)
WATER (UNII: 059QF0KO0R)
COCO-CAPRYLATE (UNII: 4828G836N6)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIDECANE (UNII: A3LZF0L939)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ARGAN OIL (UNII: 4V59G5UW9X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)
PROPANEDIOL (UNII: 5965N8W85T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)
BORON NITRIDE (UNII: 2U4T60A6YD)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYURETHANE-62 (UNII: TBK645J3J8)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
MICA (UNII: V8A1AW0880)
LEVOMENOL (UNII: 24WE03BX2T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
PANTHENOL (UNII: WV9CM0O67Z)
TOCOPHEROL (UNII: R0ZB2556P8)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
TRIDECETH-10 (UNII: G624N6MSBA)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
STANNIC OXIDE (UNII: KM7N50LOS6)
BERGAMOT OIL (UNII: 39W1PKE3JI)
JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)
CLOVE LEAF OIL (UNII: VCA5491KVF)
CETEARETH-25 (UNII: 8FA93U5T67)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
LITSEA OIL (UNII: 2XIW34BN6O)
FERRIC OXIDE RED (UNII: 1K09F3G675)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCINE (UNII: TE7660XO1C)
BEHENIC ACID (UNII: H390488X0A)
CERAMIDE NP (UNII: 4370DF050B)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CERAMIDE NG (UNII: C04977SRJ5)
SERINE (UNII: 452VLY9402)
GLUTAMIC ACID (UNII: 3KX376GY7L)
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)
ASPARTIC ACID (UNII: 30KYC7MIAI)
LEUCINE (UNII: GMW67QNF9C)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE EOS (UNII: CR0J8RN66K)
COPPER GLUCONATE (UNII: RV823G6G67)
ALANINE (UNII: OF5P57N2ZX)
LYSINE (UNII: K3Z4F929H6)
ARGININE (UNII: 94ZLA3W45F)
TYROSINE (UNII: 42HK56048U)
PHENYLALANINE (UNII: 47E5O17Y3R)
PROLINE (UNII: 9DLQ4CIU6V)
THREONINE (UNII: 2ZD004190S)
VALINE (UNII: HG18B9YRS7)
ISOLEUCINE (UNII: 04Y7590D77)
CAPROOYL PHYTOSPHINGOSINE (UNII: 2FD4Y5XL2L)
N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HISTIDINE (UNII: 4QD397987E)
ACETYL HEXAPEPTIDE-1 (UNII: 49ZWR266MZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83108-010-00	1 in 1 CARTON	01/29/2023
1		30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 83108-010-03	3 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	01/29/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/29/2023

Labeler - Rationale Group Pty Ltd (756927393)