PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30- octinoxate, octisalate, titanium dioxide, and zinc oxide lotion

PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by Have & Be Co., Ltd., Kolmar Korea Co.,LTD. Gwanjeong 2 factory, Kolmar Korea Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

OCTINOXATE 6.8%
OCTISALATE 4.5%
TITANIUM DIOXIDE 4.8%
ZINC OXIDE 5%

Purpose

Sunscreen

Use

helps prevent sunburn

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

For sunscreen use:
apply liberally and evenly 15 minutes before sun exposure
reapply at least every two 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 sunscreen 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

Inactive Ingredients

water\aqua\eau , dimethicone , glycerin , phenyl trimethicone , hexyl laurate , peg-10 dimethicone , c12-15 alkyl benzoate , niacinamide , lauryl peg-10 tris(trimethylsiloxy)silylethyl dimethicone , pentylene glycol , disteardimonium hectorite , caprylyl glycol , tocopherol , trihydroxystearin , dimethicone/vinyl dimethicone crosspolymer , ethylhexylglycerin , adenosine , magnesium sulfate , aluminum hydroxide , triethoxycaprylylsilane , synthetic fluorphlogopite , fragrance (parfum) , eucalyptus globulus oil , citrus aurantium peel oil , limonene , pinene , bht , [+/- titanium dioxide (ci 77891) , iron oxides (ci 77491) , iron oxides (ci 77492) , iron oxides (ci 77499)] <iln55607>

Other information

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

RB Premium
Beauty Balm
Multi-tasker with
Niacinamide
+ Hydrates
+ Conceals
+ Protects

Buildable coverage,
natural finish
Broad Spectrum

SPF 30

40 ml/1 .35 fl. oz.

INGREDIENTS AND APPEARANCE

PREMIUM BEAUTY BALM BROAD SPECTRUM SPF 30 
octinoxate, octisalate, titanium dioxide, and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49404-157
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	45 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	68 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	50 mg  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	48 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HEXYL LAURATE (UNII: 4CG9F9W01Q)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
CI 77491 (UNII: 1K09F3G675)
BHT (UNII: 1P9D0Z171K)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
ADENOSINE (UNII: K72T3FS567)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
CI 77492 (UNII: EX438O2MRT)
NIACINAMIDE (UNII: 25X51I8RD4)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRUS AURANTIUM PEEL OIL (UNII: 9TLV70SV6I)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
MAGNESIUM SULFATE (UNII: DE08037SAB)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
EUCALYPTUS GLOBULUS OIL (UNII: 2R04ONI662)
CI 77499 (UNII: XM0M87F357)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PINENE (UNII: 996299PUKB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49404-157-01	1 in 1 CARTON	02/09/2026
1		40 mL in 1 TUBE; 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	02/09/2026

Labeler - Have & Be Co., Ltd. (690400408)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co.,LTD. Gwanjeong 2 factory		963271750	manufacture(49404-157)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd		963271745	manufacture(49404-157)