SPF 30 Sunscreen

Product NDC
71160-338
11-digit product format
711600338
Labeler code
71160
Product ID
71160-338_0d7fa814-2190-7a91-e063-6294a90a1fc0
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; OCTISALATE; OCTOCRYLENE
Active strength
30; 100; 50; 100 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
OCTISALATE50 mg/mL
OCTOCRYLENE100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W, 5A68WGF6WM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71160-338-10SPF 30 Sunscreen10 mL in 1 BOTTLELOTION101
71160-338-10SPF 30 Sunscreen1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71160-338SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE) LOTION [TEKWELD SOLUTIONS, INC.]1Current NDC, 2 package rows20231228_dc3f8339-23c1-4882-8682-685623027bdf.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71160-338-10711600338101 BOTTLE in 1 CARTON (71160-338-10) / 10 mL in 1 BOTTLE1 bottle2023-12-20NoNoCurrent