FDA.reportPublic FDA data

Aquaphor Lip Protectant and Sunscreen

Product NDC
10356-111
11-digit product format
103560111
Labeler code
10356
Product ID
10356-111_46043588-4988-0a04-e063-6394a90a5145
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum, Avobenzone, Octinoxate, Octisalate, Octocrylene, Oxybenzone
Dosage form
LOTION
Route
TOPICAL
Labeler
Beiersdorf Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-30
Substance
PETROLATUM; AVOBENZONE; OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength
31; 3; 6.75; 4.5; 2; 5.4 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Aquaphor Lip Protectant and Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM31 g/100mL
AVOBENZONE3 g/100mL
OCTINOXATE6.75 g/100mL
OCTISALATE4.5 g/100mL
OCTOCRYLENE2 g/100mL
OXYBENZONE5.4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
95OOS7VE0YInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a43c2802-9cf1-477e-9f93-e11cf40b480dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10356-111-23Aquaphor Lip Protectant and Sunscreen10 mL in 1 TUBELOTION1010
10356-111-30Aquaphor Lip Protectant and Sunscreen0.9 mL in 1 PACKETLOTION0.910
10356-111-40Aquaphor Lip Protectant and Sunscreen2 in 1 BLISTER PACKLOTION210

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51AQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51AQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
OCTISALATEACTIVE MOIETY4X49Y0596WAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
PETROLATUMACTIVE MOIETY4T6H12BN9UAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0AQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
POLYGLYCERYL-3 DIISOSTEARATEINACTIVE INGREDIENT46P231IQV8AQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
SHEA BUTTERINACTIVE INGREDIENTK49155WL9YAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
WATERINACTIVE INGREDIENT059QF0KO0RAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VAQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10356-111AQUAPHOR LIP PROTECTANT AND SUNSCREEN (PETROLATUM, AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [BEIERSDORF INC]9Current NDC, Legacy NDC, 3 package rows20250101_a43c2802-9cf1-477e-9f93-e11cf40b480d.zip

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 6 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mederma PMDIMETHICONEPMI Branded Pharmaceuticals, Inc.26737285-f6ae-47eb-9019-33f1cfce30292026-07-15WarningsExact identifier
application number: M016
MEDERMA STRETCH MARKS THERAPYDIMETHICONEL. Perrigo Companye9366775-e85b-4403-a2c5-12d9fb3cc3fa2026-07-15WarningsExact identifier
application number: M016
Remedy Barrier Cream Cloths Fragrance FreeDIMETHICONEMedline Industries, LP00e0cd4a-6049-408a-ab3f-9edf97e6438a2026-07-14WarningsExact identifier
application number: M016
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC3e61191a-e0fa-3477-e063-6294a90a7d192026-07-14WarningsExact identifier
application number: M016
Cruex Petroleum JellyWHITE PETROLATUMMKJ BRANDS LLC459a90b8-7d52-ef70-e063-6394a90ac1d02026-07-14WarningsExact identifier
application number: M016
Mederma for KidsALLANTOINL. Perrigo Companyed4ff435-9819-46d3-9375-914712943f772026-07-14WarningsExact identifier
application number: M016
Baby 3-in-1 Diaper RashBABY 3-IN-1 DIAPER RASHWalgreens5632dde2-f59d-3a45-e063-6394a90a1a242026-07-09WarningsExact identifier
application number: M016
Drs. DIAPER RASH MAXIMUM STRENGTHZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACY161ba174-1b13-83cd-e063-6394a90af19c2026-07-09WarningsExact identifier
application number: M016
Drs. Hydrocortisone Aloe VeraHYDROCORTISONEOL PHARMA TECH,LLC0df06415-5d32-7ef8-e063-6294a90a6e5a2026-07-09WarningsExact identifier
application number: M016
SOHEJU Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.560089ff-3361-90b7-e063-6294a90ada422026-07-09WarningsExact identifier
application number: M016
Bee Venom Psoriasis Wart Caring CreamGLYCERINShantou Ximonth Biotechnology Co., Ltd.563a423c-e9dd-1cab-e063-6294a90a8c6a2026-07-09WarningsExact identifier
application number: M016
Skin Protectant with LanolinLANOLINMcKesson Medical-Surgical Inc.46df52c8-0cbf-213e-e054-00144ff88e882026-07-08WarningsExact identifier
application number: M016
Skin Protectant with LanolinLANOLINMcKesson5abe1b34-f71b-2a90-e053-2991aa0aded62026-07-08WarningsExact identifier
application number: M016
Walgreens Baby Healing BalmPETROLATUMWalgreens561c1e1e-e896-d6e9-e063-6394a90ac0e72026-07-08WarningsExact identifier
application number: M016
AD Overnight HealingAD OVERNIGHT HEALINGWellSpring Pharmaceutical Corporation57c29db6-da0c-4b28-86c0-6ac1b71224282026-07-07WarningsExact identifier
application number: M016
EczeNourish Eczema and Psoriasis Soothing OatCOLLOIDAL OATMEALVanguard Soap, LLC55f7137f-c5a5-f2ce-e063-6394a90a52802026-07-07WarningsExact identifier
application number: M016
FDS intimate Whole Body Medicated ChafingFDS INTIMATE WHOLE BODY MEDICATED CHAFINGWellSpring Pharmaceutical Corporationef01fcd8-2fe4-4076-a4d4-e730a5c2b31c2026-07-07WarningsExact identifier
application number: M016
AD First Aid MultipurposeAD FIRST AID MULTIPURPOSEWellSpring Pharmaceutical Corporation999989d8-21c2-4380-b4c1-e5421189f6ed2026-07-07WarningsExact identifier
application number: M016
AD Anti-ChafingAD ANTI-CHAFINGWellSpring Pharmaceutical Corporationd272ab4a-eb18-4f64-b925-fccf637dbb022026-07-06WarningsExact identifier
application number: M016
ECZEMA NOURISH MEDICATED CLEANSING BARCOLLOIDAL OATMEAL SKIN PROTECTANTVanguard Soap, LLC55f865dc-d88e-fe2f-e063-6294a90aa7d32026-07-06WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10356-111-231035601112310 mL in 1 TUBE (10356-111-23) 10 ml2015-06-300000-00-00NoNoCurrent
10356-111-3010356011130.9 mL in 1 PACKET (10356-111-30) 2015-06-300000-00-00NoNoCurrent
10356-111-40103560111402 TUBE in 1 BLISTER PACK (10356-111-40) / 10 mL in 1 TUBE (10356-111-23) 2 tube2015-06-300000-00-00NoNoCurrent