OTC - ACTIVE INGREDIENT SECTION
Active Ingredient
Titanium Dioxide 3.8%
Active Ingredient
Titanium Dioxide 3.8%
Use
Helps prevent sunburn
Directions
Apply liberally 15 minutes before sun exposure
Reapply at least every 2 hours
Use a water resistant sunscreen if swimming or sweating
Children under 6 months: Ask a doctor
Warnings
Skin Cancer/Skin
Aging Alert: Spending time in the
sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent
sunburn, not skin cancer or early
skin aging.
For external use
only
Do not use on
damaged or broken skin.
When using this
product keep out of eyes. Rinse with
water to remove.
Stop use and ask a
doctor if rash occurs.
Keep out of reach
of children. If product is
swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredients
Water/Eau, Cyclopentasiloxane, Butylene Glycol, Caprylic/Capric Triglyceride, Triethylhexanoin, Cyclohexasiloxane, Alcohol Denat., Cetyl PEG/PPG-10/1 Dimethicone, Squalane, Polyglyceryl-4 Isostearate, Disteardimonium Hectorite, PEG-32, Aloe Barbadensis Leaf Juice, Alumina, Calcium Aluminum Borosilicate, Caprylyl Glycol, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Panthenol, Retinyl Palmitate, Stearic Acid, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Sodium Dehydroacetate, Phenoxyethanol, [+/- (MAY CONTAIN/PEUT CONTENIR): Mica, Titanium Dioxide/CI 77891, Iron Oxides/CI 77491, CI 77492, CI 77499]
Enter section text here
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 12027-105-11 | 2025-12-08 | C162847 | 48780-1 | 9855d018-e903-cd31-e053-dbdaa90ab51a | Drug Facts |
| 12027-105-11 | 2019-11-27 | C162847 | 48780-1 | 9855d018-e903-cd31-e053-dbdaa90ab51a | Drug Facts |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 2 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 2 | |
| .ALPHA.-TOCOPHEROL ACETATE | INACTIVE INGREDIENT | 9E8X80D2L0 | 2 | |
| 1,3-BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 2 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 2 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 2 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 2 | |
| CALCIUM ALUMINUM BOROSILICATE | INACTIVE INGREDIENT | 3JRB8A35M0 | 2 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 2 | |
| CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) | INACTIVE INGREDIENT | 035JKJ76MT | 2 | |
| CUCUMBER | INACTIVE INGREDIENT | YY7C30VXJT | 2 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 2 | |
| CYCLOMETHICONE 6 | INACTIVE INGREDIENT | XHK3U310BA | 2 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 2 | |
| DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) | INACTIVE INGREDIENT | 9E4CO0W6C5 | 2 | |
| DISTEARDIMONIUM HECTORITE | INACTIVE INGREDIENT | X687XDK09L | 2 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 2 | |
| ETHYLHEXYLGLYCERIN | INACTIVE INGREDIENT | 147D247K3P | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | 2 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 2 | |
| HEXYLENE GLYCOL | INACTIVE INGREDIENT | KEH0A3F75J | 2 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 2 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 2 | |
| PANTHENOL | INACTIVE INGREDIENT | WV9CM0O67Z | 2 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 2 | |
| POLYETHYLENE GLYCOL 1450 | INACTIVE INGREDIENT | OJ4Z5Z32L4 | 2 | |
| POLYGLYCERYL-4 ISOSTEARATE | INACTIVE INGREDIENT | 820DPX33S7 | 2 | |
| SODIUM DEHYDROACETATE | INACTIVE INGREDIENT | 8W46YN971G | 2 | |
| SQUALANE | INACTIVE INGREDIENT | GW89575KF9 | 2 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 2 | |
| TETRAHEXYLDECYL ASCORBATE | INACTIVE INGREDIENT | 9LBV3F07AZ | 2 | |
| TRIETHYLHEXANOIN | INACTIVE INGREDIENT | 7K3W1BIU6K | 2 | |
| VITAMIN A PALMITATE | INACTIVE INGREDIENT | 1D1K0N0VVC | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 12027-105 | 12027-105-11 |
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| POLYETHYLENE GLYCOL 1450 | POLYETHYLENE GLYCOL 1450 | OJ4Z5Z32L4 | SUSPENSION / ORAL | 4000 mg | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | CREAM, AUGMENTED / TOPICAL | 260 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| 1,3-BUTYLENE GLYCOL | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TRANSDERMAL | 8.12 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CREAM / TOPICAL | NA | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | LOTION / TOPICAL | NA | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / AURICULAR (OTIC) | 0.01 %w/v | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL, FOAM / TOPICAL | 72 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAVENOUS | 7 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / VAGINAL | 3 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 3.6 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / AURICULAR (OTIC) | 0.05 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / OPHTHALMIC | 0.05 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | POWDER, FOR SUSPENSION / ORAL | 285 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO, SUSPENSION / TOPICAL | 1 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / SOFT TISSUE | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / RESPIRATORY (INHALATION) | 43 mg | ||
| .ALPHA.-TOCOPHEROL ACETATE | .ALPHA.-TOCOPHEROL ACETATE | 9E8X80D2L0 | TABLET / ORAL | 0.5 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INFILTRATION | 6 mg | ||
| FERROSOFERRIC OXIDE | FERROSOFERRIC OXIDE | XM0M87F357 | TABLET / ORAL | 2 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | LOTION / TOPICAL | 7 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / VAGINAL | 5 mg | ||
| POLYETHYLENE GLYCOL 1450 | POLYETHYLENE GLYCOL 1450 | OJ4Z5Z32L4 | TABLET / ORAL | 0.6 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM, AUGMENTED / TOPICAL | 10 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| POLYETHYLENE GLYCOL 1450 | POLYETHYLENE GLYCOL 1450 | OJ4Z5Z32L4 | OINTMENT / TOPICAL | 921 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRABURSAL | 0.01 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / ORAL | 4 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, COATED / ORAL | 1 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| FERRIC OXIDE YELLOW | FERRIC OXIDE YELLOW | EX438O2MRT | CAPSULE, EXTENDED RELEASE / ORAL | 7 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | PELLET / SUBCUTANEOUS | 0.97 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRALESIONAL | 0.05 %w/v | ||
| POLYETHYLENE GLYCOL 1450 | POLYETHYLENE GLYCOL 1450 | OJ4Z5Z32L4 | SUPPOSITORY / URETHRAL | 9.75 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY / NASAL | 1 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | SPRAY / TOPICAL | 540 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SPRAY, METERED / NASAL | 4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / RESPIRATORY (INHALATION) | 0.01 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 19 mg | ||
| HEXYLENE GLYCOL | HEXYLENE GLYCOL | KEH0A3F75J | OINTMENT / TOPICAL | 12 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | GEL / TRANSDERMAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | AEROSOL, FOAM / TOPICAL | 10.87 %w/w |
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 |
|---|---|---|---|---|---|---|
| 4575f792-2973-3a12-e063-6294a90aa889 | 41bbc937-9af5-4172-87b4-a8bb753facba | 2025-12-08 | Warnings | 41bbc937-9af5-4172-87b4-a8bb753facba |
Adverse event summaries are temporarily unavailable. Other product information remains available.