Intelligent SkinCare Intensive brightening kojic

Belo Sun Expert Tinted Sunscreen by

Drug Labeling and Warnings

Belo Sun Expert Tinted Sunscreen by is a Otc medication manufactured, distributed, or labeled by Intelligent Skin Care Inc., A.M. Rieta Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BELO SUN EXPERT TINTED SUNSCREEN- octyl methoxycinnamate, titanium dioxide, octocrylene, octinoxate cream 
Intelligent Skin Care Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Intelligent SkinCare Intensive brightening kojic

Active Ingredients

Active Ingredients Purpose

Octyl methoxycinnamate 6% Sunscreen

Octocrylene .60%

Oxybenzone .50%

Titanium dioxide .41%

Purpose

Purpose

Sunscreen

Use

Use

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 product is swallowed, get 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.
• children under 6 months of age: Ask a doctor.

Other Information

Other Information

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

• high sun protection product

Inactive Ingredients

Inactive Ingredients

Questions or Comments?

Questions or Comments?

+63 2 7500 3825 or inquiries@iskincareinc.com

label

BELO SUN EXPERT TINTED SUNSCREEN 
octyl methoxycinnamate, titanium dioxide, octocrylene, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82701-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1 mg  in 200 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.82 mg  in 200 mg
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.2 mg  in 200 mg
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	12 mg  in 200 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)
LEVOMENOL (UNII: 24WE03BX2T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
AVOBENZONE (UNII: G63QQF2NOX)
CETEARETH-12 (UNII: 7V4MR24V5P)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SORBITAN OLIVATE (UNII: MDL271E3GR)
EDETATE SODIUM (UNII: MP1J8420LU)
PEG-80 SORBITAN PALMITATE (UNII: 4NR71FN0IA)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
NIACINAMIDE (UNII: 25X51I8RD4)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
KOJIC ACID (UNII: 6K23F1TT52)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TROLAMINE (UNII: 9O3K93S3TK)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
TRANEXAMIC ACID (UNII: 6T84R30KC1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82701-002-01	200 mg in 1 TUBE; Type 0: Not a Combination Product	06/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	06/20/2022	12/15/2022

Labeler - Intelligent Skin Care Inc. (719667461)

Registrant - A.M. Rieta Corporation (727672787)

Revised: 12/2022

Document Id: efe0ec6b-9919-858f-e053-2a95a90aec59

34390-5

Set id: e78dac38-f01b-6ba5-e053-2995a90a35de

Version: 5

Effective Time: 20221215