smashbox

Manufacturer
SMASHBOX BEAUTY COSMETICS, INC | ELGC Kabushiki Kaisha | Estee Lauder Pennsylvania Distribution Center 2 (PADC 2) | ARAMIS, INC | ESTEE LAUDER COSMETICS DISTRIBUTION CENTER | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER COSMETICS, LTD. | ESTEE LAUDER N.V. | LEN-RON MANUFACTURING DIVISION OF ARAMIS INC | NORTEC KEYSTONE | NORTHTEC BRISTOL | NORTHTEC KEYSTONE | WHITMAN LABORATORIES, LTD. | Aveda Corporation | MANA Cosmetics Inc
Effective date
2012-01-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:30:45

Label at a glance#

Productsmashbox PHOTO FINISH SPF 15 FOUNDATION PRIMER
Active ingredientOCTINOXATE, OCTISALATE
Label structure8 sections

Dosage and administration

Apply evenly to face prior to sun exposure. Children under 6 months of age: ask doctor. The sun may cause sunburn, premature aging of skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects.

Label contents#

Full prescribing information#

Directions

DOSAGE & ADMINISTRATION SECTION

Apply evenly to face prior to sun exposure. Children under 6 months of age: ask doctor.

Sun Alert

SPL UNCLASSIFIED SECTION

The sun may cause sunburn, premature aging of skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects.

WARNING

WARNINGS SECTION

Keep out of eyes.

OTC - STOP USE SECTION

Stop using if irritation occurs.

OTC - ASK DOCTOR SECTION

If irritation persists, consult a health care practitioner.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

Apply before sun exposure.

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

7.5% Octinoxate, 5.0% Octisalate.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethyl Perfluoroisobutyl Ether, Ethyl Perfluorobutyl Ether, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Carthamus Tinctorius (Safflower) Seed Oil, Cola Acuminata Seed Extract, Camellia Oleifera Leaf Extract, Vitis Vinifera (Grape) Seed Extract, C12-15 Alkyl Benzoate, Tribehenin, Ceramide 2, PEG-10 Rapeseed Sterol, Palmitoyl Oligopeptide, Tocophenyl Acetate, Retinyl Palmitate, Water/Aqua/Eau, Ethyl Trisiloxane, Caprylyl Methicone, Methicone, Silica, Silica Silylate, Hexylene Glycol, Propylene Glycol, Triethoxycaprylylsilane, Caprylyl Glycol, Ethylhexylglycerin, Phenoxyethanol [+/- Iron Oxides (CI77491), Titanium Dioxide (CI77891)].

OTC - PURPOSE SECTION

Drug Facts

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

Keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

Rash or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

SPL UNCLASSIFIED SECTION

Dist. Smashbox Beauty
Cosmetics, Inc.
Culver City, CA 90232

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

smashbox

PHOTO FINISH
SPF 15

WITH DERMAXYL™ COMPLEX

FOUNDATION PRIMER
SPF 15 ET DERMAXYL™

1 fl. oz./30ml e

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton
PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10348-004-012020-01-31C16284748780-19d75b9d1-086d-f424-e053-dadaa90a57cesmashbox PHOTO FINISH SPF 15 FOUNDATION PRIMER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10348-004-01smashbox PHOTO FINISH SPF 15 FOUNDATION PRIMER1 in 1 CARTONLOTION11
10348-004-01smashbox PHOTO FINISH SPF 15 FOUNDATION PRIMER30 mL in 1 TUBELOTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10348-004SMASHBOX PHOTO FINISH SPF 15 FOUNDATION PRIMER (OCTINOXATE AND OCTISALATE) LOTION [SMASHBOX BEAUTY COSMETICS, INC]1Legacy NDC, 2 package rows20120126_afb9b34d-3107-45e2-ba68-9a991c09e622.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
Alkyl (C12-15) BenzoateINACTIVE INGREDIENTA9EJ3J61HQ1
Alpha-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L01
Camellia Oleifera LeafINACTIVE INGREDIENT5077EL0C601
Caprylyl GlycolINACTIVE INGREDIENT00YIU5438U1
Ceramide 2INACTIVE INGREDIENTC04977SRJ51
Cola Acuminata SeedINACTIVE INGREDIENT1F8VIW14791
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R1
Diethylamino Hydroxybenzoyl Hexyl BenzoateINACTIVE INGREDIENTANQ870JD201
EthylhexylglycerinINACTIVE INGREDIENT147D247K3P1
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G6751
Hexylene GlycolINACTIVE INGREDIENTKEH0A3F75J1
Palmitoyl OligopeptideINACTIVE INGREDIENTHO4ZT5S86C1
PEG-10 Rapeseed SterolINACTIVE INGREDIENT258O76T85M1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
Safflower OilINACTIVE INGREDIENT65UEH262IS1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU41
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JP1
TribeheninINACTIVE INGREDIENT8OC9U7TQZ01
TriethoxycaprylylsilaneINACTIVE INGREDIENTLDC331P08E1
Vitamin A PalmitateINACTIVE INGREDIENT1D1K0N0VVC1
Vitis Vinifera SeedINACTIVE INGREDIENTC34U15ICXA1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10348-00410348-004-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 208 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii candidate
21 equally ranked IID candidates
Alpha-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSHAMPOO, SUSPENSION / TOPICAL3 %w/vExact identifier — unii candidate
40 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675CAPSULE, COATED / ORAL0.12 mgExact identifier — unii candidate
21 equally ranked IID candidates
Alpha-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675DROPS / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675CAPSULE, COATED PELLETS / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSUSPENSION / ORAL113 mgExact identifier — unii candidate
40 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, DELAYED RELEASE / ORAL37 mgExact identifier — unii candidate
21 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE, COATED PELLETS / ORAL69 mgExact identifier — unii candidate
49 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPDROPS / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
81 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4INSERT / VAGINAL8 mgExact identifier — unii candidate
49 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
21 equally ranked IID candidates
Safflower OilSAFFLOWER OIL65UEH262ISLOTION / TOPICAL3510 mgExact identifier — unii candidate
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675CAPSULE / ORAL5 mgExact identifier — unii candidate
21 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
Hexylene GlycolHEXYLENE GLYCOLKEH0A3F75JOINTMENT / TOPICAL12 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, EXTENDED RELEASE / ORAL90 mgExact identifier — unii candidate
40 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675CAPSULE, EXTENDED RELEASE / ORAL5 mgExact identifier — unii candidate
21 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675TABLET, FILM COATED, EXTENDED RELEASE / ORAL3.6 mgExact identifier — unii candidate
21 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii candidate
49 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED, EXTENDED RELEASE / ORAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii candidate
81 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675SUSPENSION, EXTENDED RELEASE / ORAL2.7 mgExact identifier — unii candidate
21 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii candidate
49 equally ranked IID candidates
Silicon DioxideSILICON DIOXIDEETJ7Z6XBU4SYSTEM / TRANSDERMAL35 mgExact identifier — unii candidate
49 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSOAP / TOPICAL1 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY / VAGINALNAExact identifier — unii candidate
40 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3FILM / BUCCAL1.48 mgExact identifier — unii candidate
81 equally ranked IID candidates
Hexylene GlycolHEXYLENE GLYCOLKEH0A3F75JSOLUTION / TOPICAL0.3 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
Titanium DioxideTITANIUM DIOXIDE15FIX9V2JPCAPSULE, EXTENDED RELEASE / ORAL67 mgExact identifier — unii candidate
40 equally ranked IID candidates

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
914e2639-b8ad-40a3-9843-035cfab7f440afb9b34d-3107-45e2-ba68-9a991c09e6222012-01-23WarningsExact identifier
spl id: 914e2639-b8ad-40a3-9843-035cfab7f440
spl set id: afb9b34d-3107-45e2-ba68-9a991c09e622

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.