RODIAL BROAD SPECTRUM SPF 50 DROPS ANTI-BLUE LIGHT AND POLLUTION- octocrylene, octinoxate, oxybenzone, octisalate, avobenzone lotion

Rodial Broad Spectrum SPF 50 Drops Anti-Blue Light and Pollution by

Drug Labeling and Warnings

Rodial Broad Spectrum SPF 50 Drops Anti-Blue Light and Pollution by is a Otc medication manufactured, distributed, or labeled by Rodial Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Octocrylene 10% Octinoxate 7.5% Oxybenzone 6% Octisalate 5% Avobenzone 3%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun 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 and evenly 15 minutes before sun exposure
• children under 6 months of age: ask a doctor
• 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 value of 15 or higher and other sun protection measures including: Sun Protection Measures.
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses
• use a water-resistant sunscreen if swimming or sweating
• reapply at least every 2 hours

Other information

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

Inactive ingredients

Water, Butylene Glycol, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, PEG -100 Stearate, Octyldodecanol, Jojoba Esters, Glyceryl Stearate SE, Propanediol, Phenoxyethanol, Helianthus Annuus (Sunflower) Seed Wax, Saccharide Isomerate, Methyl Methacrylate Crosspolymer, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Benzyl Alcohol, Bisabolol, Echium Plantagineum Seed Oil, Lecithin, Buddleja Officinalis Flower Extract, 1,2-Hexanediol, Carbomer, Disodium EDTA, Sodium Hyaluronate, Acacia Decurrens Flower Extract, Polyglycerin-3, Parfum (Fragrance), Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sodium Hydroxide, Biosaccharide Gum-4, Dehydroacetic Acid, Ethylbisiminomethylguaiacol Manganese Chloride, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Citric Acid, Sodium Citrate, Limonene, Alpha-isomethyl Ionone, Tocopherol, Citronellol.

Questions or comments?

• Side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Package Labeling:

INGREDIENTS AND APPEARANCE

RODIAL BROAD SPECTRUM SPF 50 DROPS ANTI-BLUE LIGHT AND POLLUTION 
octocrylene, octinoxate, oxybenzone, octisalate, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52456-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	60 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-100 STEARATE (UNII: YD01N1999R)
OCTYLDODECANOL (UNII: 461N1O614Y)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PROPANEDIOL (UNII: 5965N8W85T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
SACCHARIDE ISOMERATE (UNII: W8K377W98I)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LEVOMENOL (UNII: 24WE03BX2T)
ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ACACIA DECURRENS FLOWER (UNII: 8PHF3LSM61)
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU)
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
TOCOPHEROL (UNII: R0ZB2556P8)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
JOJOBA OIL (UNII: 724GKU717M)
BUDDLEJA OFFICINALIS FLOWER (UNII: 274707Y672)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52456-022-01	1 in 1 CARTON	07/20/2021
1		31 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 Drug	M020	07/20/2021

Labeler - Rodial Ltd. (237407262)