OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS: OCTINOXATE 7.50% [] OCTISALATE 5.00% [] AVOBENZONE 3.00% [] HOMOSALATE 2.90% [] OCTOCRYLENE 2.70%
SUNTINTS
- Manufacturer
- MAKEUP ART COSMETICS | Len-Ron Manufacturing Division of Aramis Inc. | Estee Lauder Inc | Northtec Keystone | Northtec Bristol | Estee Lauder Pennsylvania Distribution Center 2 | Estee Lauder Cosmetics Ltd. | Estee Lauder Cosmetics, Ltd. | Estee Lauder Cosmetics Distribution Centre | ELGC K.K. | Estee Lauder N.V. | Whitman Laboratories Ltd. | Aveda Corporation | Pennsylvania Logistics Center (PALC)
- Effective date
- 2012-04-26
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:32:13
Label at a glance#
ProductSUNTINTS LIQUID LIP BALM SPF 20
Active ingredientOCTINOXATE, OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure4 sections
Label contents#
Full prescribing information#
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS: OCTYLDODECANOL [] NEOPENTYL GLYCOL DIHEPTANOATE [] ETHYLCELLULOSE [] DIISOSTEARYL MALATE [] BUTYLOCTYL SALICYLATE [] DICAPRYLYL CARBONATE [] TOCOPHERYL ACETATE [] POLYGONUM CUSPIDATUM ROOT EXTRACT [] DEXTRIN PALMITATE [] CALCIUM ALUMINUM BOROSILICATE [] CALCIUM SODIUM BOROSILICATE [] CAPRYLYL GLYCOL [] HEXYLENE GLYCOL [] SILICA [] TIN OXIDE [] LINOLEIC ACID [] HYDROGENATED DILINOLEYL ALCOHOL [] VANILLIN [] PHENOXYETHANOL [] [+/- MICA [] IRON OXIDES (CI 77491, CI 77492, CI 77499) [] TITANIUM DIOXIDE (CI 77891) [] BISMUTH OXYCHLORIDE (CI 77163) [] BLUE 1 LAKE (CI 42090) [] CARMINE (CI 75470) [] RED 6 (CI 15850) [] RED 7 LAKE (CI 15850) [] RED 28 LAKE (CI 45410) [] RED 30 LAKE (CI 73360) [] RED 33 LAKE (CI 17200) [] YELLOW 5 LAKE (CI 19140) [] YELLOW 6 LAKE (CI 15985)]
WARNINGS SECTION
WARNING: STOP USE IF IRRITATION OCCURS.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
MAC
SUNTINTS SPF 20
LIQUID BALM
10 ML/ .33 FL OZ LIQ
MAKE UP ART COSMETICS, DIST
NY,NY 10022
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 40046-0034-1 | 2019-11-13 | C162847 | 48780-1 | 97449f38-c3ce-f6ea-e053-dbdaa90aa703 | d203780c-e770-435a-acff-0162e1483605 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 40046-0034-1 | SUNTINTSLIQUID LIP BALM SPF 20 | 1 in 1 CARTON | LIPSTICK | 1 | 1 | |
| 40046-0034-2 | SUNTINTSLIQUID LIP BALM SPF 20 | 10 mL in 1 VIAL | LIPSTICK | 10 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 40046-0034 | SUNTINTS LIQUID LIP BALM SPF 20 (OCTINOXATE, OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE) LIPSTICK [MAKEUP ART COSMETICS] | 1 | Legacy NDC, 2 package rows | 20120606_d203780c-e770-435a-acff-0162e1483605.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| AVOBENZONE | ACTIVE INGREDIENT | G63QQF2NOX | 1 | |
| HOMOSALATE | ACTIVE INGREDIENT | V06SV4M95S | 1 | |
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| OCTOCRYLENE | ACTIVE INGREDIENT | 5A68WGF6WM | 1 | |
| AVOBENZONE | ACTIVE MOIETY | G63QQF2NOX | 1 | |
| HOMOSALATE | ACTIVE MOIETY | V06SV4M95S | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OCTISALATE | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| OCTOCRYLENE | ACTIVE MOIETY | 5A68WGF6WM | 1 | |
| ALPHA-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 1 | |
| BUTYLOCTYL SALICYLATE | INACTIVE INGREDIENT | 2EH13UN8D3 | 1 | |
| CALCIUM ALUMINOSILICATE | INACTIVE INGREDIENT | 3L00JH8411 | 1 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| COCHINEAL | INACTIVE INGREDIENT | TZ8Z31B35M | 1 | |
| D&C RED NO. 28 | INACTIVE INGREDIENT | 767IP0Y5NH | 1 | |
| D&C RED NO. 30 | INACTIVE INGREDIENT | 2S42T2808B | 1 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | 1 | |
| D&C RED NO. 6 | INACTIVE INGREDIENT | 481744AI4O | 1 | |
| D&C RED NO. 7 | INACTIVE INGREDIENT | ECW0LZ41X8 | 1 | |
| DICAPRYLYL CARBONATE | INACTIVE INGREDIENT | 609A3V1SUA | 1 | |
| DIISOSTEARYL MALATE | INACTIVE INGREDIENT | QBS8A3XZGQ | 1 | |
| ETHYLCELLULOSES | INACTIVE INGREDIENT | 7Z8S9VYZ4B | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C YELLOW NO. 5 | INACTIVE INGREDIENT | I753WB2F1M | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| HEXYLENE GLYCOL | INACTIVE INGREDIENT | KEH0A3F75J | 1 | |
| LINOLEIC ACID | INACTIVE INGREDIENT | 9KJL21T0QJ | 1 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| NEOPENTYL GLYCOL DIHEPTANOATE | INACTIVE INGREDIENT | 5LKW3C543X | 1 | |
| OCTYLDODECANOL | INACTIVE INGREDIENT | 461N1O614Y | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| POLYGONUM CUSPIDATUM ROOT | INACTIVE INGREDIENT | 7TRV45YZF7 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| STANNIC OXIDE | INACTIVE INGREDIENT | KM7N50LOS6 | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| VANILLIN | INACTIVE INGREDIENT | CHI530446X | 1 |
Products#
Every source-derived product name is available through these pages.
- SUNTINTS LIQUID LIP BALM SPF 20
- OCTINOXATE, OCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
- OCTINOXATE
- OCTISALATE
- AVOBENZONE
- HOMOSALATE
- OCTOCRYLENE
- OCTYLDODECANOL
- NEOPENTYL GLYCOL DIHEPTANOATE
- ETHYLCELLULOSES
- DIISOSTEARYL MALATE
- BUTYLOCTYL SALICYLATE
- DICAPRYLYL CARBONATE
- ALPHA-TOCOPHEROL ACETATE
- POLYGONUM CUSPIDATUM ROOT
- CALCIUM ALUMINOSILICATE
- CAPRYLYL GLYCOL
- HEXYLENE GLYCOL
- SILICON DIOXIDE
- STANNIC OXIDE
- LINOLEIC ACID
- VANILLIN
- PHENOXYETHANOL
- FERRIC OXIDE RED
- MICA
- TITANIUM DIOXIDE
- FD&C BLUE NO. 1
- COCHINEAL
- D&C RED NO. 6
- D&C RED NO. 7
- D&C RED NO. 28
- D&C RED NO. 30
- D&C RED NO. 33
- FD&C YELLOW NO. 5
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 40046-0034 | 40046-0034-2, 40046-0034-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, DELAYED RELEASE / ORAL | 3.2 mg | ||
| VANILLIN | VANILLIN | CHI530446X | ELIXIR / ORAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | CAPSULE / ORAL | 12.32 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE PARTICLES / ORAL | 170 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | SUSPENSION, EXTENDED RELEASE / ORAL | 70 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | TABLET, COATED / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE / ORAL | 254 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | LIQUID / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, DELAYED RELEASE / ORAL | 40 mg | ||
| HEXYLENE GLYCOL | HEXYLENE GLYCOL | KEH0A3F75J | CREAM / TOPICAL | 385 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | POWDER, FOR SUSPENSION / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SUSPENSION / ORAL | NA | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PASTE / DENTAL | 34 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SOLUTION / TOPICAL | 0.06 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | LOTION / TOPICAL | NA | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET / ORAL | 180 mg | ||
| VANILLIN | VANILLIN | CHI530446X | LIQUID / ORAL | NA | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | CAPSULE / ORAL | 1 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE / ORAL | 2 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, COATED / ORAL | 7.93 mg | ||
| D&C RED NO. 7 | D&C RED NO. 7 | ECW0LZ41X8 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 0.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | ELIXIR / ORAL | 0.15 mg | ||
| VANILLIN | VANILLIN | CHI530446X | TABLET, FILM COATED / ORAL | 5 mg | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | FILM / TRANSDERMAL | 32.44 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GEL / DENTAL | 19 %w/w | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | LOZENGE / BUCCAL | NA | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| D&C RED NO. 7 | D&C RED NO. 7 | ECW0LZ41X8 | TABLET / ORAL | 0.5 mg | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | TABLET, SUGAR COATED / ORAL | NA | ||
| ALPHA-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | FILM / BUCCAL | 0.09 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CONCENTRATE / ORAL | NA | ||
| FD&C YELLOW NO. 5 | FD&C YELLOW NO. 5 | I753WB2F1M | SOLUTION / ORAL | 1 mg/1ml | ||
| VANILLIN | VANILLIN | CHI530446X | TABLET, COATED / ORAL | 65.5 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOAP / TOPICAL | 0.01 %w/w | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| D&C RED NO. 33 | D&C RED NO. 33 | 9DBA0SBB0L | CONCENTRATE / ORAL | 0.02 mg/1ml | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET, CHEWABLE / ORAL | 3 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| OCTYLDODECANOL | OCTYLDODECANOL | 461N1O614Y | SYSTEM / TRANSDERMAL | 4.05 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | POWDER, FOR SOLUTION / ORAL | 0.04 mg/5ml | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| D&C RED NO. 28 | D&C RED NO. 28 | 767IP0Y5NH | SUSPENSION / ORAL | 2.5 mg/5ml | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| D&C RED NO. 30 | D&C RED NO. 30 | 2S42T2808B | TABLET, EXTENDED RELEASE / ORAL | 0.22 mg | ||
| ETHYLCELLULOSES | ETHYLCELLULOSE | 7Z8S9VYZ4B | SYSTEM / TOPICAL | 10 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1422a024-5cb7-4816-8c80-5981039d666d | d203780c-e770-435a-acff-0162e1483605 | 2012-04-26 | Warnings | 1422a024-5cb7-4816-8c80-5981039d666d d203780c-e770-435a-acff-0162e1483605 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.