FDA.reportPublic FDA data

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 218 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLARINS Multi-Active Jour Niacinamide and Sea Holly Extract Sunscreen SPF 15AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELaboratoires Clarinsa43d0d4f-94de-4c4b-a17a-63a819d5d2932025-04-07WarningsExact identifier
application number: M020
Gangnam Glow Sunscreen 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.30cc2e35-f752-8285-e063-6294a90afbf52025-04-07WarningsExact identifier
application number: M020
Carmex Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.26f8dc88-2096-4fa1-81ae-ea92fe1f353d2025-04-07WarningsExact identifier
application number: M020
Vacation Instant BrowningAVOBENZONE OCTISALATE OCTOCRYLENEVacation Inc.13028f61-3f62-22cc-e063-6394a90a6bf12025-04-04WarningsExact identifier
application number: M020
LBri Pure n Natural SPF 30ZINC OXIDEL'BRI HEALTH & BEAUTY8350791d-5cf2-4358-9f85-9384d35be9f42025-04-03WarningsExact identifier
application number: M020
SHEER MINERAL SUNSCREENZINC OXIDEPlant Devas Inc. dba evanhealyf620ef44-f30c-4cc9-bc82-28dc4a47a8da2025-04-02WarningsExact identifier
application number: M020
CLEAR GLOW BROAD SPECTRUM SUNCREEN SPF 50AVOBENZONE, HOMOSALATE OCTISALATE, OCTOCRYLENENAKED SUNDAYS PTY LTD0116cffa-3415-746b-e063-6394a90ab3b32025-04-01WarningsExact identifier
application number: M020
HYDRATING SUNSCREEN MOISTURIZER BROAD SPECTRUM SPF50 SPF 50AVOBENZONE, HOMOSALATE OCTISALATE,NAKED SUNDAYS PTY LTD04293280-e74a-f293-e063-6394a90a06f62025-04-01WarningsExact identifier
application number: M020
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5aab267-b33b-a40d-e053-2a95a90a9d792025-04-01WarningsExact identifier
application number: M020
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5beb9cd-aa3b-2b37-e053-2995a90a84092025-04-01WarningsExact identifier
application number: M020
Glow Go Lip OilAVOBENZONE 30MG/G, HOMOSALATE 100MG/G, OCTOCRYLENE 100MG/G, OCTISALATE 50MG/G,NAKED SUNDAY PTY LTDe5bdc0c8-af2c-1096-e053-2995a90a89172025-04-01WarningsExact identifier
application number: M020
Mesoestetic Mesoprotech Melan 130 Pigment ControlAVOBENZONE, HOMOSALATE, OCTOCRYLENEMESOESTETIC PHARMA GROUP SL3b50e874-9665-4df4-8b3a-fc932c29f3f62025-04-01WarningsExact identifier
application number: M020
AVON BEYOND GLOW SUN MOISTURIZERAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG HOUSEHOLD & HEALTH CARE LTD.30c83f4f-9de0-6fbf-e063-6394a90af1ae2025-04-01WarningsExact identifier
application number: M020
EltaMD UV DailyOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc6dde7055-5f77-4a7f-a182-c03e1f30bfaa2025-03-31WarningsExact identifier
application number: M020
natural lip balm SPF15( chocolate sundae) 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.319e8e26-b29d-4627-e063-6294a90acfba2025-03-31WarningsExact identifier
application number: M020
Face Shield Cream SPF 30OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE, AVOBENZONEVege Labs31aad575-a5d1-42b0-e063-6294a90a6c812025-03-31WarningsExact identifier
application number: M020
SOLMED SUNSCREEN FACE SHIELDAVOBENZONE, ETHYLHEXYL SALICYLATE, HOMOSALATE, OCTOCRYLENEFEELFREE LLC31b077cc-32b9-78e6-e063-6394a90a155a2025-03-31WarningsExact identifier
application number: M020
TATCHA THE SILK SUNSCREENZINC OXIDETATCHA INC.7799042a-d2de-480e-a8a3-827b3dc279072025-03-31WarningsExact identifier
application number: M020
Cotz Sensitive SPF 40 SunscreenZINC OXIDEFallien Cosmeceuticals, LTD.885a674b-3457-4dfe-a801-529094b004992025-03-31WarningsExact identifier
application number: M020
EltaMD UV Daily TintedOCTINOXATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Incad8aafdf-f3bc-497f-9792-20c2911c12d02025-03-31WarningsExact 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