FDA.reportPublic FDA data

SPF 15 Lip Conditioner

Manufacturer
OJAS, LLC
Effective date
2016-07-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:37

Label at a glance#

ProductSPF 15 Lip Conditioner
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Avobenzone - 3%

Homosalate - 5%

Octinoxate - 5%

Octocrylene - 2.75%

OTC - PURPOSE SECTION

Purpose: Sunscreen

INDICATIONS & USAGE SECTION

Uses:

  • Helps protect against sunburn and chapped lips.

WARNINGS SECTION

Warnings:

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

Directions:

  • Apply generously before sun exposure and as needed.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Simmondsia Chinensis (Jojoba) Seed Oil, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Palmitate, Organic Persea Gratissima (Avocado) Oil, Dipalmitoyl Hydroxyproline, Flavor, Tetrahexyldecyl Ascorbate, Butylene/Ethylene/Styrene Copolymer, Tocopheryl Acetate, Tribehenin, Sorbitan Isostearate, Lecithin, Caprylic/Capric Triglyceride, Physalis Angulata, Extract, Leontopodium Alpinum Meristem Cell Culture, Silica Dimethyl Silylate, Polygonum Aviculare Extract, Butylene Glycol, Sodium Hyaluronate, Water, Glycerin, Palmitoyl Tripeptide-1, Citrus Aurantium Dulcis (Orange) Callus Culture Extract, Xanthan Gum.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Made In USA

Distributed By OJAS, LLC

OjasSkin.Com

image descriptionimage description

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70867-102-112020-01-31C16284748780-19d75b9d0-d01e-f424-e053-dadaa90a57ce06407f65-889d-4d85-92bb-b6d8e4d57b22
70867-102-522020-01-31C16284748780-19d75b9d0-d01e-f424-e053-dadaa90a57ce06407f65-889d-4d85-92bb-b6d8e4d57b22

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70867-102-11SPF 15 Lip Conditioner2 mL in 1 TUBECREAM21
70867-102-12SPF 15 Lip Conditioner7.5 mL in 1 BOTTLE, PUMPCREAM7.51
70867-102-52SPF 15 Lip Conditioner1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70867-102SPF 15 LIP CONDITIONER (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE) CREAM [OJAS, LLC]1Legacy NDC, 3 package rows20160727_06407f65-889d-4d85-92bb-b6d8e4d57b22.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70867-10270867-102-11, 70867-102-12, 70867-102-52

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTOCRYLENE5A68WGF6WMACTIB
JOJOBA OIL724GKU717MIACT
STYRENE44LJ2U959VIACT
ETHYLHEXYL PALMITATE2865993309IACT
AVOCADO OIL6VNO72PFC1IACT
DIPALMITOYL HYDROXYPROLINEE6AHA53N1HIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
1-BUTENELY001N554LIACT
ETHYLENE91GW059KN7IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIBEHENIN8OC9U7TQZ0IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
EGG PHOSPHOLIPIDS1Z74184RGVIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PHYSALIS ANGULATAW4TKW9D5GGIACT
LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERMWN6IZU3XMIACT
SILICA DIMETHYL SILYLATEEU2PSP0G0WIACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
HYALURONATE SODIUMYSE9PPT4THIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
CITRUS SINENSIS FLOWERH02N5LQ5F6IACT
XANTHAN GUMTTV12P4NEEIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
89765ac8-a3c6-462e-9385-b7533df12a8506407f65-889d-4d85-92bb-b6d8e4d57b222016-07-26WarningsExact identifier
spl id: 89765ac8-a3c6-462e-9385-b7533df12a85
spl set id: 06407f65-889d-4d85-92bb-b6d8e4d57b22

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.