SPF 30 Sunscreen

Product NDC
71160-331
11-digit product format
711600331
Labeler code
71160
Product ID
71160-331_0d7021f4-3029-3554-e063-6294a90a64d4
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE
Dosage form
LOTION
Route
TOPICAL
Labeler
Tekweld Solutions, Inc.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-20
Substance
AVOBENZONE; HOMOSALATE; OCTOCRYLENE; OCTISALATE
Active strength
30; 100; 100; 50 mg/mL; mg/mL; mg/mL; mg/mL
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
SPF 30 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE100 mg/mL
OCTOCRYLENE100 mg/mL
OCTISALATE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ea9f4d57-b00c-48ce-b833-9690be98bffdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71160-331-30SPF 30 Sunscreen30 mL in 1 BOTTLELOTION301
71160-331-30SPF 30 Sunscreen1 in 1 CARTONLOTION11
71160-331-31SPF 30 Sunscreen30 mL in 1 BOTTLELOTION301
71160-331-31SPF 30 Sunscreen1 in 1 CARTONLOTION11
71160-331-32SPF 30 Sunscreen1 in 1 CARTONLOTION11
71160-331-32SPF 30 Sunscreen30 mL in 1 BOTTLELOTION301
71160-331-60SPF 30 Sunscreen60 mL in 1 BOTTLELOTION601
71160-331-60SPF 30 Sunscreen1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71160-331SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [TEKWELD SOLUTIONS, INC.]1Current NDC, 8 package rows20231228_ea9f4d57-b00c-48ce-b833-9690be98bffd.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 299 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MELAN SPF-30 Antioxidant Body Mist SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEMELAN INC.66b7c899-46fd-41a6-9a96-ebbf2b68ea252024-05-02WarningsExact identifier
application number: M020
No7 Restore and Renew Face and Neck Multi Action Day Cream Sunscreen Broad Spectrum SPF 30AVOBENZONE,OCTISALATE, OCTOCRYLENE.BCM Ltd4ce3fe14-e33d-cbf6-e063-6294a90a42fe2024-04-30WarningsExact identifier
application number: M020
bareMinerals BAREPRO 24HR Wear Skin-Perfecting Matte Liquid Foundation Fair 10 NeutralZINC OXIDEOrveon Global US LLC1740393b-f8a3-475b-e063-6394a90a6fa82024-04-29WarningsExact identifier
application number: M020
SUMMER GELEE SPF-30HOMOSALATE, OCTISALATE, OCTOCRYLENESUMMER GELEE LLCbc85db65-2acc-4b39-9189-f8916c487b612024-04-27WarningsExact identifier
application number: M020
SUMMER GELEE SPF-4HOMOSALATE, OCTISALATESUMMER GELEE LLCc9ec81ad-0478-4026-bc6c-5582eb012b8d2024-04-27WarningsExact identifier
application number: M020
Natural Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESarati International, Inc.16ef922d-78d1-1e70-e063-6394a90a3bbf2024-04-25WarningsExact identifier
application number: M020
PRISMA PROTECT SPF30OCTOCRYLENE, HOMOSALATE, OCTISALATE, AND AVOBENZONEDermalogica, LLC.e0e6d779-c491-43ed-acc9-274d1b60c1ff2024-04-25WarningsExact identifier
application number: M020
Degil Sun SPF 30 SunscreenHOMOSALATE, OCTISALATE, OXYBENZONE,AVOBENZONE, OCTOCRYLENEDegil Safety Products (1989) Inc16d8d1d0-e531-2a64-e063-6394a90a5b9c2024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 AlabasterTITANIUM DIOXIDEChantecaille Beaute Ince1c562b8-76c0-4c6e-9276-900784c8639e2024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 WheatTITANIUM DIOXIDEChantecaille Beaute Inc89f19f7a-60e3-4080-a49a-a4eb3e6c27de2024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 AuraTITANIUM DIOXIDEChantecaille Beaute Incde441a6c-55e3-4b11-afb3-d7db3c6971f02024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 BlissTITANIUM DIOXIDEChantecaille Beaute Inc16d9e226-7694-922a-e063-6394a90aea852024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 GlowTITANIUM DIOXIDEChantecaille Beaute Incf868fe4f-4c10-4f0f-9f1d-008f067744082024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 NudeTITANIUM DIOXIDEChantecaille Beaute Inccb8feddc-ae98-42ea-ad1e-583dcacfa5d92024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 OpalineTITANIUM DIOXIDEChantecaille Beaute Inc1c918b4b-763b-48bf-9ae3-661eabafee162024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 TanTITANIUM DIOXIDEChantecaille Beaute Incfdf05545-5a21-4238-b0d3-e3fcdfe866ff2024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 TopazTITANIUM DIOXIDEChantecaille Beaute Inc2012f671-7889-4e29-b70f-215cbc9dbdc72024-04-24WarningsExact identifier
application number: M020
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 VanillaTITANIUM DIOXIDEChantecaille Beaute Inc7133c47d-ed1c-43e9-8cdf-42f7b2f215f52024-04-24WarningsExact identifier
application number: M020
Eco Lips PlantPod Sunscreen Lip Balm Vanilla SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONEEco Lips. Inc.fd8edc49-762a-b718-e053-6394a90a65f52024-04-23WarningsExact identifier
application number: M020
SKINPERFECT PRIMER SPF30ZINC OXIDEDermalogica, LLC.692f9cda-eb6c-431f-a575-3778c6e12e3b2024-04-23WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71160-331-30711600331301 BOTTLE in 1 CARTON (71160-331-30) / 30 mL in 1 BOTTLE1 bottle2023-12-20NoNoCurrent
71160-331-31711600331311 BOTTLE in 1 CARTON (71160-331-31) / 30 mL in 1 BOTTLE1 bottle2023-12-20NoNoCurrent
71160-331-32711600331321 BOTTLE in 1 CARTON (71160-331-32) / 30 mL in 1 BOTTLE1 bottle2023-12-20NoNoCurrent
71160-331-60711600331601 BOTTLE in 1 CARTON (71160-331-60) / 60 mL in 1 BOTTLE1 bottle2023-12-20NoNoCurrent