FDA.reportPublic FDA data

Sunscreen SPF 50

Product NDC
49757-010
11-digit product format
497570010
Labeler code
49757
Product ID
49757-010_4d4f240d-5656-cc29-e063-6294a90a7903
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone 3% , Homosalate 10%,Octisalate 5%
Dosage form
SPRAY
Route
TOPICAL
Labeler
Rocky Mountain
Application
M20
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-21
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE
Active strength
3; 10; 5 g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sunscreen SPF 50
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE3 g/100g
HOMOSALATE10 g/100g
OCTISALATE5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG63QQF2NOX, V06SV4M95S, 4X49Y0596W

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49757-010-06Sunscreen SPF 50170 g in 1 CONTAINERSPRAY1704
49757-010-09Sunscreen SPF 50453 g in 1 BOTTLESPRAY4534
49757-010-12Sunscreen SPF 50907 g in 1 CONTAINERSPRAY9074
49757-010-22Sunscreen SPF 503629 g in 1 CONTAINERSPRAY36294

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49757-010-0649757001006170 g in 1 CONTAINER170 gHistorical
49757-010-0949757001009453 g in 1 BOTTLE (49757-010-09) 453 g2025-08-21NoNoCurrent
49757-010-1249757001012907 g in 1 CONTAINER (49757-010-12) 907 g2025-08-21NoNoCurrent
49757-010-22497570010223629 g in 1 CONTAINER (49757-010-22) 3629 g2025-08-21NoNoCurrent