DOSAGE & ADMINISTRATION SECTION
DIRECTIONS: Apply liberally before sun
exposure and as needed.
DIRECTIONS: Apply liberally before sun
exposure and as needed.
WARNING:
Discontinue use if skin irritation
develops or increases. If irritation
persists, consult a health care
practitioner.
ACTIVE INGREDIENTS/INGRÉDIENTS
ACTIFS: OCTINOXATE 5.0 %,
OXYBENZONE 3.0%.
Uses:Helps prevent sunburn. Higher SPF
gives more sunburn protection.
INACTIVE INGREDIENTS / INGRÉDIENTS
INACTIFS: DIISOPROPYL DIMER DILINOLEATE
POLYGLYCERYL-2 DIISOSTEARATE
LANOLIN
PETROLATUM
POLYBUTENE
STEARYL/PPG-3 MYRISTYL ETHER DIMER DILINOLEATE
SUCROSE ACETATE ISOBUTYRATE
MICROCRYSTALLINE WAX/CIRE MICROCRISTALLINE
POLYETHYLENE
OZOKERITE
CERESIN
PHENYL TRIMETHICONE
POLYMETHYLSILSESQUIOXANE
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL
CALCIUM SODIUM BOROSILICATE
BARIUM SULFATE
CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE
SILICA
TOCOPHERYL ACETATE
ALLANTOIN
ETHYLENE/PROPYLENE/STYRENE COPOLYMER
ACRYLATES COPOLYMER
PARFUM/FRAGRANCE
ALLYL METHACRYLATES CROSSPOLYMER
WATER/EAU
LECITHIN
C12-15 ALKYL BENZOATE
HYDROXYETHYL UREA
BUTYLENE/ETHYLENE/STYRENE COPOLYMER
TIN OXIDE
PENTYLENE GLYCOL
HYDROLYZED SILK
TAMARINDUS INDICA SEED EXTRACT
RETINYL PALMITATE
UREA
ASCORBYL PALMITATE
BETA-CAROTENE
MAY CONTAIN:
MICA/CI 77019
IRON OXIDES
TITANIUM DIOXIDE/CI 77891
RED 33 LAKE/CI 17200
RED 7 LAKE
RED 6/CI 15850
RED 6 LAKE/CI 15850
BISMUTH OXYCHLORIDE/CI 77163
BLUE 1 LAKE/CI 42090
CARMINE/CI 75470
YELLOW 5 LAKE/CI 19140
YELLOW 6 LAKE
YELLOW 10 LAKE/CI 47005
RED 7/CI 15850
RED 28 LAKE/CI 45410
RED 36/CI 12085
RED 40 LAKE/CI 16035
ORANGE 5/CI 45370
RED 21/CI 45380
RED 22 LAKE/CI 45380
RED 27 LAKE/CI 45410
RED 30 LAKE/CI 73360
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1 | Product name | 1 | 20201123 |
| 85bed648-23ca-4804-98e6-e36aee999cad | Product name | 1 | 20190717 |
| 80de93b4-8a94-428d-beb7-d644353ee70b | Product name | 1 | 20180424 |
| eb4f7d5b-1286-40dc-b8bf-ad87ff51c688 | Product name | 1 | 20170522 |
| db8eb201-78c7-4590-8a71-fac0a539bd8c | Product name | 1 | 20170404 |
| 141092be-5eb5-452e-9f69-2d350aa70a87 | Product name | 1 | 20161208 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10096-0188-1 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c7a4-621f-e053-dbdaa90a74ad | 7a906a9d-2b3e-4119-ad62-30d68c50850a |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10096-0188-1 | Ultra Color RichMega Impact | 3 g in 1 CASE | LIPSTICK | 3 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 10096-0188 | ULTRA COLOR RICH MEGA IMPACT (OCTINOXATE, OXYBENZONE) LIPSTICK [AVON PRODUCTS, INC.] | 1 | Legacy NDC, 1 package rows | 20100706_7a906a9d-2b3e-4119-ad62-30d68c50850a.zip |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OXYBENZONE | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| OXYBENZONE | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| ALLANTOIN | INACTIVE INGREDIENT | 344S277G0Z | 1 | |
| ASCORBYL PALMITATE | INACTIVE INGREDIENT | QN83US2B0N | 1 | |
| BARIUM SULFATE | INACTIVE INGREDIENT | 25BB7EKE2E | 1 | |
| BETA CAROTENE | INACTIVE INGREDIENT | 01YAE03M7J | 1 | |
| BISMUTH OXYCHLORIDE | INACTIVE INGREDIENT | 4ZR792I587 | 1 | |
| C12-15 ALKYL BENZOATE | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| LANOLIN | INACTIVE INGREDIENT | 7EV65EAW6H | 1 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 1 | |
| PENTYLENE GLYCOL | INACTIVE INGREDIENT | 50C1307PZG | 1 | |
| PETROLATUM | INACTIVE INGREDIENT | 4T6H12BN9U | 1 | |
| PHENYL TRIMETHICONE | INACTIVE INGREDIENT | DR0K5NOJ4R | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| UREA | INACTIVE INGREDIENT | 8W8T17847W | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 10096-0188 | 10096-0188-1 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| OCTINOXATE | 4Y5P7MUD51 | ACTIB |
| OXYBENZONE | 95OOS7VE0Y | ACTIB |
| LANOLIN | 7EV65EAW6H | IACT |
| PETROLATUM | 4T6H12BN9U | IACT |
| PHENYL TRIMETHICONE | DR0K5NOJ4R | IACT |
| BARIUM SULFATE | 25BB7EKE2E | IACT |
| ALLANTOIN | 344S277G0Z | IACT |
| WATER | 059QF0KO0R | IACT |
| C12-15 ALKYL BENZOATE | A9EJ3J61HQ | IACT |
| PENTYLENE GLYCOL | 50C1307PZG | IACT |
| UREA | 8W8T17847W | IACT |
| ASCORBYL PALMITATE | QN83US2B0N | IACT |
| BETA CAROTENE | 01YAE03M7J | IACT |
| MICA | V8A1AW0880 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| BISMUTH OXYCHLORIDE | 4ZR792I587 | IACT |
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 |
|---|---|---|---|---|---|---|
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | CAPSULE / ORAL | 12 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / RESPIRATORY (INHALATION) | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | CREAM / TOPICAL | 0.02 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | INSERT, EXTENDED RELEASE / OPHTHALMIC | 0.4 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| UREA | UREA | 8W8T17847W | TABLET, EFFERVESCENT / ORAL | 60 mg | ||
| BARIUM SULFATE | BARIUM SULFATE | 25BB7EKE2E | IMPLANT / SUBCUTANEOUS | 15 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | SPRAY / NASAL | NA | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | SOLUTION / TOPICAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / VAGINAL | 4084 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 1 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM, AUGMENTED / TOPICAL | 26 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | LOTION / TOPICAL | 1.5 %w/w | ||
| UREA | UREA | 8W8T17847W | DOUCHE / VAGINAL | 8 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | TABLET / ORAL | 3.5 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / OPHTHALMIC | 3 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CAPSULE / VAGINAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT, AUGMENTED / TOPICAL | 81.94 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / BUCCAL | 11 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / AURICULAR (OTIC) | NA | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | SHAMPOO / TOPICAL | 2 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SPONGE / TOPICAL | NA | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | LIQUID / RESPIRATORY (INHALATION) | NA | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / TOPICAL | 10 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| BETA CAROTENE | BETA CAROTENE | 01YAE03M7J | EMULSION / ORAL | NA | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | CREAM / TOPICAL | 10 mg | ||
| BETA CAROTENE | BETA CAROTENE | 01YAE03M7J | CREAM / TOPICAL | NA | ||
| UREA | UREA | 8W8T17847W | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| UREA | UREA | 8W8T17847W | INSERT / VAGINAL | 50 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | SOAP / TOPICAL | 0.85 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | CREAM / TOPICAL | 4213 mg | ||
| LANOLIN | LANOLIN | 7EV65EAW6H | OINTMENT / RECTAL | 105 mg | ||
| BARIUM SULFATE | BARIUM SULFATE | 25BB7EKE2E | SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE | 10 mg | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | SYSTEM / TOPICAL | 0.04 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| PETROLATUM | PETROLATUM | 4T6H12BN9U | OINTMENT / OPHTHALMIC | 88.4 %w/w | ||
| UREA | UREA | 8W8T17847W | SYSTEM / TOPICAL | 840 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| UREA | UREA | 8W8T17847W | TABLET, COATED / ORAL | 0.02 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE, DENTIFRICE / DENTAL | 0.4 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg |
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 |
|---|---|---|---|---|---|---|
| ae64975b-ac6a-45b7-831c-4c003032bcca | 7a906a9d-2b3e-4119-ad62-30d68c50850a | 2009-12-22 | Warnings | ae64975b-ac6a-45b7-831c-4c003032bcca 7a906a9d-2b3e-4119-ad62-30d68c50850a |
Adverse event summaries are temporarily unavailable. Other product information remains available.