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

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
Sunscreen SPF 50
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal 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
9647b817-653f-45e5-b71a-ee9ad82e84ebAvailable on FDA.report

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

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 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jack Black Intense Lip Therapy SPF25, Black Tea and BlackberryLIP BALM SUNSCREENJack Black, LLC172a70bc-8a09-4258-b9bf-cf3c67ff76132026-09-08WarningsExact identifier
application number: M20
SPF 50 Chemical Mysterman SLAMAVABENZONE 3% HOMOSALATE 10% OCTOCRYLENE 6%Slam Lotionfe741ecb-06dd-4c1c-b983-8470560a28742026-06-29WarningsExact identifier
application number: M20
Sunscreen SPF 50AVOBENZONE 3% , HOMOSALATE 10%,OCTISALATE 5%Rocky Mountain9647b817-653f-45e5-b71a-ee9ad82e84eb2026-03-18WarningsExact identifier
application number: M20
ndc (product): 49757-010
Kids Sunscreen SPF 50AVOBENZONE 3% , HOMOSALATE 10%,OCTISALATE 5%Rocky Mountain34891204-3485-44ac-aaf1-80d57593128c2026-03-18WarningsExact identifier
application number: M20
SPF 50 Chemical Fragrance free SLAMAVABENZONE 3% HOMOSALATE 10% OCTOCRYLENE 6%Slam Lotionadce05cf-da63-49bc-bada-78665e2b7ce82026-03-17WarningsExact identifier
application number: M20
SPF 50 Chemical Gentleman SLAMAVABENZONE 3% HOMOSALATE 10% OCTOCRYLENE 6%Slam Lotionde261b15-395e-4e9c-beea-24bea0b695a82026-03-17WarningsExact identifier
application number: M20
Sunscreen SPF 30AVOBENZONE 3% , HOMOSALATE 10%,OCTISALATE 5%Rocky Mountain1e7a9254-1785-4765-a765-9b2efc1264462026-01-14WarningsExact identifier
application number: M20
Men scented sunscreen SPF 50 gentleman SLAMAVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%Slam Lotion3e8616ea-942a-4b14-a8f3-2d8778f0a94f2025-08-15WarningsExact identifier
application number: M20
Men scented sunscreen SPF 50 mysterman SLAMAVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%Slam Lotionc0dfe7af-700b-49c4-8dc4-ef6f3697d54e2025-08-15WarningsExact identifier
application number: M20
Men scented sunscreen SPF 50 woodsman SLAMAVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%Slam Lotion04c28d41-b4b7-41d3-85e0-4afca7bca3e62025-08-12WarningsExact identifier
application number: M20
Men scented sunscreen SPF 50 beachman SLAMAVABENZONE 3% HOMOSALATE 10% OCTISALATE 5%Slam Lotionfec77941-caae-41d2-bfcc-51f222ba29532025-08-12WarningsExact identifier
application number: M20

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