FDA.reportPublic FDA data

PHOTO FINISH INVISIBLE SPF 45 BROAD SPECTRUM SPF 45 PRIMER

Product NDC
10348-019
11-digit product format
103480019
Labeler code
10348
Product ID
10348-019_41c4e135-c6e0-82d4-e063-6294a90a0ad3
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE
Dosage form
LIQUID
Route
TOPICAL
Labeler
SMASHBOX BEAUTY COSMETICS, INC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-01
Substance
OCTISALATE; OCTOCRYLENE; HOMOSALATE; AVOBENZONE
Active strength
45; 70; 70; 30 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
PHOTO FINISH INVISIBLE SPF 45 BROAD SPECTRUM SPF 45 PRIMER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTISALATE45 mg/mL
OCTOCRYLENE70 mg/mL
HOMOSALATE70 mg/mL
AVOBENZONE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup
V06SV4M95SInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
41c4e135-c6df-82d4-e063-6294a90a0ad3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10348-019-01PHOTO FINISH INVISIBLE SPF 45 BROAD SPECTRUM SPF 45 PRIMER1 in 1 CARTONLIQUID11
10348-019-01PHOTO FINISH INVISIBLE SPF 45 BROAD SPECTRUM SPF 45 PRIMER30 mL in 1 TUBELIQUID301
10348-019-02PHOTO FINISH INVISIBLE SPF 45 BROAD SPECTRUM SPF 45 PRIMER1 in 1 CARTONLIQUID11
10348-019-02PHOTO FINISH INVISIBLE SPF 45 BROAD SPECTRUM SPF 45 PRIMER10 mL in 1 TUBELIQUID101
10348-019-03PHOTO FINISH INVISIBLE SPF 45 BROAD SPECTRUM SPF 45 PRIMER5 mL in 1 TUBELIQUID51

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 50 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sky and Sol Face and Body Sunscreen SPF 50NON- NANO ZINC OXIDEDelta Ecommerce LLC473a6ade-1f0a-c711-e063-6294a90a2b832026-03-30WarningsExact identifier
application number: M020
Vacation by Vacation Scent and Shimmer DuoAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation Inc.0c4e6fa1-c78d-4f9d-969f-135d4ed67daf2026-03-30WarningsExact identifier
application number: M020
Marie originals - ProActive SunscreenZINC OXIDE SUNSCREENVEGANIC SKN LIMITED4e3204bf-eda4-2bdf-e063-6394a90ae4292026-03-29WarningsExact identifier
application number: M020
Sport UltraAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECARDINAL HEALTH 110, LLC. DBA LEADER37c5dcf7-dc2d-624f-e063-6394a90ae9922026-03-29WarningsExact identifier
application number: M020
ULTRALIGHT AGE DEFENSE SPF 50ZINC OXIDEGuangzhou Origin Beauty Cosmetics Co., Ltd.4e36a743-7906-2b7b-e063-6294a90af3142026-03-29WarningsExact identifier
application number: M020
Stay Put Sunscreen SPF 30OCTINOXATE 7.50% OCTISALATE 5.00% OXYBENZONE 4.00% HOMOSALATE 10.00%Sawyer Products Inc7ecba495-a912-4697-8287-2e5836e610e12026-03-27WarningsExact identifier
application number: M020
UV SOLUTIONS BRIGHTENING TINTED BROAD SPECTRUM SPF 50 SUNSCREEN NIACINAMIDE ANTIOXIDANTS DARK SHADETITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLC4e0bd355-99c6-8cf4-e063-6294a90ab4b32026-03-27WarningsExact identifier
application number: M020
Vacation X AZ Lemon Tea Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEVacation INC.61c48acc-f589-40d3-b289-b777db5551db2026-03-27WarningsExact identifier
application number: M020
Truly Solar Baby Suncreen SPF 45HOMOSALATE 15% OCTISALATE 5% OCTOCRYLENE 10% AVOBENZONE 3%Truly Beauty, Inc38e6c6fc-d8b9-4196-96c7-0f6d5d06da022026-03-26WarningsExact identifier
application number: M020
burndHOMOSALATE, OCTINOXATE, ZINC OXIDEBURND LLC31cf923e-fdde-790b-e063-6294a90a60ee2026-03-26WarningsExact identifier
application number: M020
SUNNYSIDEKICK UVA/UVB Broad Spectrum SPF 30 Brush-On MineralZINC OXIDE, TITANIUM DIOXIDEClassic Cosmetics LLC4df3b8c0-71bc-acdd-e063-6394a90a35c02026-03-26WarningsExact identifier
application number: M020
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.4df77564-9da0-7e48-e063-6294a90a5e6b2026-03-26WarningsExact identifier
application number: M020
Mentholatum Natural Ice Protect Plus SPF 30 Protect Plus SPF 30AVOBENZONE, DIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company3804a14b-be7c-a973-e063-6294a90ac7fc2026-03-25WarningsExact identifier
application number: M020
Softlips Oasis Pineapple CoconutDIMETHICONE, OXYBENZONE, OCTINOXATEThe Mentholatum Companyc504463a-28bf-4161-875f-ef73520931c52026-03-25WarningsExact identifier
application number: M020
Mentholatum Natural Ice Cherry, SPF 15 CherryDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company37f2c3a6-7790-c8ec-e063-6294a90ace222026-03-25WarningsExact identifier
application number: M020
Mentholatum Natural Ice - Original, SPF 15 OriginalDIMETHICONE, OCTINOXATE, OCTISALATEThe Mentholatum Company37dc44aa-17b2-8721-e063-6294a90a34f62026-03-25WarningsExact identifier
application number: M020
ISNTREE HYALURONIC ACID DAILY SUNGELAVOBENZONE, HOMOSALATE, OCTISALATEISNTREE Inc.0ef5d5ce-3bdf-dffc-e063-6394a90aad542026-03-25WarningsExact identifier
application number: M020
Silkscreen Sheer Tint Mineral Light-MediumTITANIUM DIOXIDE, ZINC OXIDECurology4ddbe349-6880-a5fc-e063-6294a90a275c2026-03-25WarningsExact identifier
application number: M020
AXIS-Y Complete No-Stress Physical Sunscreen V.3ZINC OXIDEAsia Master Trade Co.,Ltd1f310fb1-185a-b467-e063-6294a90a72fe2026-03-25WarningsExact identifier
application number: M020
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4e0450ca-147a-91d7-e063-6394a90ae73b2026-03-25WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10348-019-01103480019011 TUBE in 1 CARTON (10348-019-01) / 30 mL in 1 TUBE1 tube2025-11-01NoNoCurrent
10348-019-02103480019021 TUBE in 1 CARTON (10348-019-02) / 10 mL in 1 TUBE1 tube2025-11-01NoNoCurrent
10348-019-03103480019035 mL in 1 TUBE (10348-019-03) 5 ml2025-11-01NoNoCurrent