FDA.reportPublic FDA data

Hello Sunday The One For Your Lips Clear Lip Balm SPF 50

Manufacturer
Kao USA Inc.
Effective date
2025-11-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:16:34

Key Label Information#

Active Ingredients And Purpose

Active Ingredients

AVOBENZONE 3% HOMOSALATE 7.3% OCTISALATE 5% OCTOCRYLENE 9%

Purpose

Sunscreen

Uses

Uses

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

Warnings

Warnings

For external use only

Directions And Dosage

Directions

Apply generously to lips before sun exposure. Reapply frequently Do not swallow Sun Protection Measures: 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: limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses

Other Label Information

Inactive Ingredients

POLYISOBUTENE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SILICA DIMETHYL SILYLATE, BUTYLOCTYL SALICYLATE, SQUALANE, DICAPRYLYL CARBONATE, OCTYLDODECANOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCERYL BEHENATE, FRAGRANCE, SODIUM HYALURONATE, TOCOPHEROL, ORYZA SATIVA (RICE) EXTRACT, ORYZA SATIVA (RICE) GERM EXTRACT, SYNTHETIC WAX, STEARALKONIUM BENTONITE, PHYSALIS ANGULATA EXTRACT, 1,2-HEXANEDIOL, BISABOLOL, CAPRYLYL GLYCOL, ETHYLHEXYL PALMITATE, GLYCINE SOJA (SOYBEAN) OIL, PROPYLENE CARBONATE, POLYGLYCERYL-3 DIISOSTEARATE, TRIHYDROXYSTEARIN, GLUCOMANNAN, BENZYL BENZOATE.

Questions or comments?

1-888-426-0695 Monday-Friday, 9 a.m. - 5 p.m. EST

Product Packaging

Label Images#

lip balm
lip balm

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10596-806-012025-11-17C16284748780-12cef2736-8679-d83d-e063-dadaa90ab31fHello Sunday The One For Your Lips Clear Lip Balm SPF 50
10596-806-012025-01-30C16284748780-12cef2736-8679-d83d-e063-dadaa90ab31fHello Sunday The One For Your Lips Clear Lip Balm SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10596-806-01Hello Sunday The One For Your Lips Clear Lip Balm SPF 5015 mL in 1 TUBESTICK152
10596-806-01Hello Sunday The One For Your Lips Clear Lip Balm SPF 501 in 1 CARTONSTICK12

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10596-80610596-806-01

Ingredients#

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
POLYISOBUTYLENE (1300 MW)241BN7J12YIACT
HYALURONATE SODIUMYSE9PPT4THIACT
RICE GERM7N2B70SFEZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TRIHYDROXYSTEARIN06YD7896S3IACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
SQUALANEGW89575KF9IACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
OCTYLDODECANOL461N1O614YIACT
SHEA BUTTERK49155WL9YIACT
TOCOPHEROLR0ZB2556P8IACT
GLYCERYL MONOBEHENATEA626UU0W2AIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
AVOBENZONEG63QQF2NOXACTIB
PROPYLENE CARBONATE8D08K3S51EIACT
ETHYLHEXYL PALMITATE2865993309IACT
LEVOMENOL24WE03BX2TIACT
KONJAC MANNAN36W3E5TAMGIACT
PHYSALIS ANGULATA WHOLEW4TKW9D5GGIACT
CAPRYLYL GLYCOL00YIU5438UIACT
OCTOCRYLENE5A68WGF6WMACTIB
BENZYL BENZOATEN863NB338GIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SOYBEAN OIL241ATL177AIACT
HOMOSALATEV06SV4M95SACTIB

Complete SPL Sections#

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

AVOBENZONE 3% HOMOSALATE 7.3% OCTISALATE 5% OCTOCRYLENE 9%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

Apply generously to lips before sun exposure. Reapply frequently Do not swallow Sun Protection Measures: 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: limit time in the sun, especially from 10 a.m. – 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

POLYISOBUTENE, CAPRYLIC/CAPRIC TRIGLYCERIDE, SILICA DIMETHYL SILYLATE, BUTYLOCTYL SALICYLATE, SQUALANE, DICAPRYLYL CARBONATE, OCTYLDODECANOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCERYL BEHENATE, FRAGRANCE, SODIUM HYALURONATE, TOCOPHEROL, ORYZA SATIVA (RICE) EXTRACT, ORYZA SATIVA (RICE) GERM EXTRACT, SYNTHETIC WAX, STEARALKONIUM BENTONITE, PHYSALIS ANGULATA EXTRACT, 1,2-HEXANEDIOL, BISABOLOL, CAPRYLYL GLYCOL, ETHYLHEXYL PALMITATE, GLYCINE SOJA (SOYBEAN) OIL, PROPYLENE CARBONATE, POLYGLYCERYL-3 DIISOSTEARATE, TRIHYDROXYSTEARIN, GLUCOMANNAN, BENZYL BENZOATE.

Questions or comments?

OTC - QUESTIONS SECTION

1-888-426-0695 Monday-Friday, 9 a.m. - 5 p.m. EST

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML