LUMINOUS SUNSCREEN SPF 50- zinc oxide, titanium dioxide cream

Luminous Sunscreen SPF 50 by

Drug Labeling and Warnings

Luminous Sunscreen SPF 50 by is a Otc medication manufactured, distributed, or labeled by CLINICAL SKIN LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Titanium Dioxide 1.58%

Zinc Oxide 22.4%

Purpose

Sunscreen

Use

• 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

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
• 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 suncsreen with a Broad Spectrum SPF value 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-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: Ask a doctor.

Other information

• store at Room Temperature (15 C - 25 C (59 F-77 F)
• protect the product in this container from excessive heat and direct sun

Inactive ingredients

Water, Caprylic/Capric Triglyceride, Dicaprylyl Carbonate, Butyloctyl Salicylate, Squalane, Glycerin, Cetearyl Alcohol, Hydrated Silica, Polyhydroxystearic Acid, Coco-Glucoside, Phenoxyethanol, C20-22 Alkyl Phosphate, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, C20-22 Alcohols, Alumina, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrogen Dimethicone, Acacia Senegal Gum, Ethylhexylglycerin, Tocopheryl Acetate, Aloe Barbadensis Leaf, Xanthan Gum, Sodium Sulfate, Camellia Sinensis Leaf Extract, Polysorbate 60, Sorbitan Isostearate, Sodium Hyaluronate, Nasturtium Officinale Flower/Leaf Extract, Tocopherol, Ascorbic Acid, Hydrolyzed Rice Protein, Ceteareth-25, Citric Acid, Hedychium Coronarium Root Extract, Cetyl Alcohol, Sodium Benzoate, Potassium Sorbate, Glycine Soja (Soybean) Protein, Superoxide Dismutase, Behenic Acid, Ceramide NP, Cholesterol, Ceramide NS, Ceramide AP, Ceramide EOP, Ceramide EOS, Glucose, Sodium Dextran Sulfate, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Plankton Extract, Ascorbyl Palmitate

Principal Display Panel

CLINICAL SKIN

Formulated WITH A.C.E. TECHNOLOGY

LUMINOUS SUNSCREEN

UV BROAD SPECTRUM

SPF 50

100% mineral

Shields Against

UVA/UVB rays

RADIANT FINISH

1.7 fl oz/50 ml

INGREDIENTS AND APPEARANCE

LUMINOUS SUNSCREEN SPF 50 
zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84248-028
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22.4 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.58 mg

Inactive Ingredients
Ingredient Name	Strength
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BEHENIC ACID (UNII: H390488X0A)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SQUALANE (UNII: GW89575KF9)
ACACIA SENEGAL GUM (UNII: 5C5403N26O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM SULFATE (UNII: 0YPR65R21J)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
COCO-GLUCOSIDE (UNII: ICS790225B)
POLYSORBATE 60 (UNII: CAL22UVI4M)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
ALUMINA (UNII: LMI26O6933)
HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
CERAMIDE NP (UNII: 4370DF050B)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
CERAMIDE NS (UNII: V7M2259XJM)
NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)
CERAMIDE AP (UNII: F1X8L2B00J)
XANTHAN GUM (UNII: TTV12P4NEE)
SOY PROTEIN (UNII: R44IWB3RN5)
ALOE BARBADENSIS LEAF (UNII: ZY81Z83H0X)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
SODIUM HYALURONATE (UNII: YSE9PPT4TH)
HYDROLYZED RICE PROTEIN (ENZYMATIC; 2000 MW) (UNII: J9JP2XE45M)
CETEARETH-25 (UNII: 8FA93U5T67)
GLUCOSE (UNII: 5SL0G7R0OK)
DEXTRAN SULFATE SODIUM (5000 MW) (UNII: V5LWP0C2L5)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
CETYL ALCOHOL (UNII: 936JST6JCN)
CERAMIDE EOS (UNII: CR0J8RN66K)
C20-22 ALCOHOLS (UNII: O4M0347C6A)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUPEROXIDE DISMUTASE (UNII: W2T4YRA9AD)
CAPROOYL SPHINGOSINE (UNII: 038753E78J)
TOCOPHEROL (UNII: R0ZB2556P8)
HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)
CERAMIDE 9 (UNII: 88KCS7120E)
CAPROOYL PHYTOSPHINGOSINE (UNII: 2FD4Y5XL2L)
CHOLESTEROL (UNII: 97C5T2UQ7J)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ISOSTEARIC ACID (UNII: X33R8U0062)
CITRIC ACID (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84248-028-01	1 in 1 CARTON	12/02/2024
1		50 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 Drug	M020	12/02/2024

Labeler - CLINICAL SKIN LLC (106954468)

Registrant - CLINICAL SKIN LLC (106954468)