THE ENRICHED CREME BROAD SPECTRUM SPF 15- zinc oxide emulsion

The Enriched Creme Broad Spectrum SPF 15 by

Drug Labeling and Warnings

The Enriched Creme Broad Spectrum SPF 15 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 12%

Purpose

Sunscreen

Uses

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

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.

Directions

• 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

Aqua (Water), Dimethicone , Glycerin, Pentylene Glycol, PEG-10 Dimethicone, Tribehenin PEG-20 Esters, Ethylhexyl Methoxycrylene, Coco-Caprylate, Polyhydroxystearic Acid, Propanediol, Argania Spinosa Kernel Oil, Dimethicone Crosspolymer, Polyurethane-62, Tocopheryl Acetate, CI 77891 (Titanium Dioxide), Polyacrylamide, 1,2-Hexanediol, Silica, C13-14 Isoparaffin, Maltodextrin, Mica, Sodium Potassium Aluminum Silicate, Tocopherol, Butylene Glycol, Limonene, Tocotrienols, Laureth-7, Caprylhydroxamic Acid, Disodium EDTA, Hydrolyzed Keratin, Santalum Spicatum (Sandalwood) Seed Oil, Trideceth-10, Voandzeia Subterranea Seed Extract, Behenyl Alcohol, Bisabolol, Polyglyceryl-10 Pentastearate, Helianthus Annuus (Sunflower) Seed Oil, Citrus Aurantium Dulcis (Orange) Oil, Anigozanthos Flavidus Flower Extract, Davidsonia Jerseyana Fruit Extract, Syzygium Luehmannii Fruit Extract, Tin Oxide, Citric Acid, Ceteareth-25, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Fructose, Litsea Cubeba Fruit Oil, Sodium Hydroxide, Urea, Citral, Citrus Aurantium Bergamia (Bergamot) Leaf Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Oil, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Sodium Stearyl Lactylate, CI 77491 (Iron Oxides), Ceramide NP, 7-Dehydrocholesterol, Cetyl Alcohol, Elaeis Guineensis (Palm) Oil, Melanin, Allantoin, Maltose, Sodium Chloride, Sodium Lactate, Sodium PCA, Trehalose, Magnesium Aspartate, Zinc Gluconate, Linalool, Behenic Acid, Ceramide AP, Cholesterol, Ceramide NG, Phytosphingosine, Ceramide NS Sodium Hyaluronate, Glycine, Acetyl Tetrapeptide-22, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Serine, Glutamic Acid, Ceramide EOP, Ceramide EOS, Copper Gluconate, Glucose, Aspartic Acid, Leucine, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Alanine, Lysine, Ethylhexylglycerin, Arginine, Tyrosine, Phenylalanine, Proline, Threonine, Valine, Isoleucine, Histidine.

Package Labeling:

Package Labeling:3ml

Package Labeling:5ml

INGREDIENTS AND APPEARANCE

THE ENRICHED CREME BROAD SPECTRUM SPF 15 
zinc oxide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83108-000
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	120 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
COCO-CAPRYLATE (UNII: 4828G836N6)
PROPANEDIOL (UNII: 5965N8W85T)
ARGAN OIL (UNII: 4V59G5UW9X)
POLYURETHANE-62 (UNII: TBK645J3J8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICA (UNII: V8A1AW0880)
TOCOPHEROL (UNII: R0ZB2556P8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
TOCOTRIENOLS (UNII: KP2MW85SSQ)
LAURETH-7 (UNII: Z95S6G8201)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SANDALWOOD (UNII: 3641YW25N2)
TRIDECETH-10 (UNII: G624N6MSBA)
BAMBARA GROUNDNUT (UNII: 4T235SD5XE)
DOCOSANOL (UNII: 9G1OE216XY)
LEVOMENOL (UNII: 24WE03BX2T)
POLYGLYCERYL-10 PENTASTEARATE (UNII: PMX5872701)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ORANGE OIL, COLD PRESSED (UNII: AKN3KSD11B)
ANIGOZANTHOS FLAVIDUS FLOWERING TOP (UNII: RP2O43NDZC)
SYZYGIUM LUEHMANNII FRUIT (UNII: 47QSB3L4KG)
STANNIC OXIDE (UNII: KM7N50LOS6)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CETEARETH-25 (UNII: 8FA93U5T67)
BERGAMOT OIL (UNII: 39W1PKE3JI)
CITRUS MAXIMA FRUIT RIND OIL (UNII: 8U3877WD44)
LEMON OIL, COLD PRESSED (UNII: I9GRO824LL)
FRUCTOSE (UNII: 6YSS42VSEV)
LITSEA OIL (UNII: 2XIW34BN6O)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
UREA (UNII: 8W8T17847W)
CITRAL (UNII: T7EU0O9VPP)
CITRUS BERGAMIA LEAF OIL (UNII: ZVY8741I1V)
JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)
GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)
CLOVE LEAF OIL (UNII: VCA5491KVF)
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)
FERRIC OXIDE RED (UNII: 1K09F3G675)
CERAMIDE NP (UNII: 4370DF050B)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
CETYL ALCOHOL (UNII: 936JST6JCN)
PALM OIL (UNII: 5QUO05548Z)
ALLANTOIN (UNII: 344S277G0Z)
MALTOSE (UNII: XJ6S9RV06F)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
TREHALOSE (UNII: B8WCK70T7I)
MAGNESIUM ASPARTATE (UNII: R17X820ROL)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BEHENIC ACID (UNII: H390488X0A)
CERAMIDE AP (UNII: F1X8L2B00J)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CERAMIDE NG (UNII: C04977SRJ5)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
GLYCINE (UNII: TE7660XO1C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SERINE (UNII: 452VLY9402)
GLUTAMIC ACID (UNII: 3KX376GY7L)
CERAMIDE EOS (UNII: CR0J8RN66K)
COPPER GLUCONATE (UNII: RV823G6G67)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
ASPARTIC ACID (UNII: 30KYC7MIAI)
LEUCINE (UNII: GMW67QNF9C)
CAPROOYL PHYTOSPHINGOSINE (UNII: 2FD4Y5XL2L)
N-HEXANOYLSPHINGOSINE (UNII: 038753E78J)
ALANINE (UNII: OF5P57N2ZX)
LYSINE (UNII: K3Z4F929H6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ARGININE (UNII: 94ZLA3W45F)
TYROSINE (UNII: 42HK56048U)
PHENYLALANINE (UNII: 47E5O17Y3R)
PROLINE (UNII: 9DLQ4CIU6V)
THREONINE (UNII: 2ZD004190S)
VALINE (UNII: HG18B9YRS7)
ISOLEUCINE (UNII: 04Y7590D77)
HISTIDINE (UNII: 4QD397987E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83108-000-00	1 in 1 BOX	11/25/2022
1		50 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 83108-000-03	3 mL in 1 JAR; Type 0: Not a Combination Product	12/08/2022
3	NDC: 83108-000-05	5 mL in 1 JAR; Type 0: Not a Combination Product	12/08/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/25/2022

Labeler - Rationale Group Pty Ltd (756927393)