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 343 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm IvoryOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS97e7ece8-a705-4988-ba52-6d3f115735212021-12-01WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 ChestnutOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS6a44f926-11b4-4bc4-8d5d-721a89c4f0cc2021-11-09WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 HazelnutOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASb58af664-b0fd-4585-8417-7c20954d7aff2021-11-09WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 UmberOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS7bbd1334-fae8-4274-b927-a099af7643452021-11-09WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 CedarOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS970571f9-3d6b-46ae-a668-745de1911fa22021-11-09WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 WheatOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS542e1b2e-f63c-466b-b5ac-6c147a0e9dec2021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Warm BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS21b65c12-6f67-4053-9508-6b2709cc1fb82021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool BeigeOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS8ea4c470-ebd5-448e-b72a-ccd1113de0ab2021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 HoneyOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASfd9689a4-21d1-49f0-bf59-b8e1da72cd162021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 DuneOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASc23b6a87-8cf9-4be3-8306-2285e7e926c12021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 PorcelainOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASa93cb6c6-d7c2-43cc-a2e8-961f896a977e2021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 LatteOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS32d99955-1593-426b-958e-5dcf689192a32021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 TawnyOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS762deb57-754b-46a9-9907-de05e11da1782021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 AmberOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS3b5366e4-180a-4b98-9524-63601ae9d2702021-11-08WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool VanillaOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS9a0ab557-e1f3-4c89-a9ae-0f81fbc5032e2021-11-04WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 CalicoOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS3e67abb5-84a4-4a78-9ea3-9fd57cbeb4822021-11-04WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 Cool IvoryOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS477d79c1-f169-4d0e-a95d-f5e832855f0d2021-11-04WarningsExact identifier
application number: M020
Anhydrous SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.1510cae2-9c8f-45ba-b088-67747af3d30c2021-07-15WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 TawnyOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS3f0480e4-b2c3-962c-e063-6294a90a4f232021-07-13WarningsExact identifier
application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool IvoryOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASaa708db4-ad90-49b7-a250-5698e4c7d3d62021-07-13WarningsExact 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