Indications and uses
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
flormar REBORN BB CREAM SUNSCREEN BROAD SPECTRUM SPF 30 CP13 Nude Ivory
- Manufacturer
- Kosan Kozmetik Sanayi ve Ticaret A.S.
- Effective date
- 2019-10-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-05-31 23:01:08
Label at a glance#
Productflormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP13 Nude Ivory
Active ingredientOCTINOXATE
Label structure7 sections
Dosage and administration
Apply to face with a make-up sponge. Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures inclu...
Label contents#
Full prescribing information#
Active ingredient
Octinoxate 5%
Purpose
Sunscreen
Uses
- Helps prevent sunburn.
- If used as directed with other sun protection measures (see
Directions
), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
For external use only
Do not use
on damaged or brokenskin
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 swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply to face with a make-up sponge.
- Apply liberally 15 minutes before sun exposure.
- Reapply at least every 2 hours.
- Use a water resistant sunscreen if swimming or sweating.
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m. – 2 p.m.
- Wear long-sleeved shirts, pants, hats and sunglasses.
- Children under 6 months of age: Ask a doctor.
Other information
- Protect the product in this container from excessive heat and direct sun
Inactive ingredients
neopentyl glycol diethylhexanoate, ethylhexyl palmitate, polyethylene, hydrogenated polyisobutene, isononyl isononanoate, octyldodecyl stearoyl stearate, aluminum starch octenyl succinate, candelilla (Candelilla cera) wax, pentaerythrityl tetrabehenate, isocetyl stearoyl stearate, jojoba (Simmondsia chinensis) seed oil, squalane, nylon-12, polyglyceryl-3 diisostearate, cyclopentasiloxane, polymethylsilsesquioxane, dimethicone/vinyl dimethicone crosspolymer, triethoxycaprylylsilane, aluminum hydroxide, fragrance, polyglyceryl-3 polydimethyl siloxyethyl dimethicone, silica, stearic acid, PEG-8, tocopherol, ascorbyl palmitate, ascorbic acid, citric acid, linalool, butylphenyl methylpropional, alpha-isomethyl ionone, citronellol, benzyl salicylate, geraniol, coumarin, titanium dioxide, iron oxides
Product Labels
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61722-164-00 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-3dd1-a910-e053-dadaa90a0b85 | flormar REBORN BB CREAM SUNSCREEN BROAD SPECTRUM SPF 30 CP13 Nude Ivory |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61722-164-00 | flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP13 Nude Ivory | 12 g in 1 CONTAINER | CREAM | 12 | 5 | |
| 61722-164-00 | flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP13 Nude Ivory | 1 in 1 BOX | CREAM | 1 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61722-164 | FLORMAR REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP13 NUDE IVORY (OCTINOXATE) CREAM [KOSAN KOZMETIK SANAYI VE TICARET A.S.] | 5 | Legacy NDC, 2 package rows | 20191019_a386b28f-02eb-4f82-90b1-d2c42a78bcc0.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 3 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 3 | |
| .BETA.-CITRONELLOL, (R)- | INACTIVE INGREDIENT | P01OUT964K | 3 | |
| ALUMINUM HYDROXIDE | INACTIVE INGREDIENT | 5QB0T2IUN0 | 3 | |
| ALUMINUM STARCH OCTENYLSUCCINATE | INACTIVE INGREDIENT | I9PJ0O6294 | 3 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | 3 | |
| ASCORBYL PALMITATE | INACTIVE INGREDIENT | QN83US2B0N | 3 | |
| BENZYL SALICYLATE | INACTIVE INGREDIENT | WAO5MNK9TU | 3 | |
| BUTYLPHENYL METHYLPROPIONAL | INACTIVE INGREDIENT | T7540GJV69 | 3 | |
| CANDELILLA WAX | INACTIVE INGREDIENT | WL0328HX19 | 3 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | 3 | |
| COUMARIN | INACTIVE INGREDIENT | A4VZ22K1WT | 3 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 3 | |
| ETHYLHEXYL PALMITATE | INACTIVE INGREDIENT | 2865993309 | 3 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 3 | |
| GERANIOL | INACTIVE INGREDIENT | L837108USY | 3 | |
| HIGH DENSITY POLYETHYLENE | INACTIVE INGREDIENT | UG00KM4WR7 | 3 | |
| ISOCETYL STEAROYL STEARATE | INACTIVE INGREDIENT | IJV4LS383R | 3 | |
| ISOMETHYL-.ALPHA.-IONONE | INACTIVE INGREDIENT | 9XP4LC555B | 3 | |
| ISONONYL ISONONANOATE | INACTIVE INGREDIENT | S4V5BS6GCX | 3 | |
| JOJOBA OIL | INACTIVE INGREDIENT | 724GKU717M | 3 | |
| LINALOOL, (+/-)- | INACTIVE INGREDIENT | D81QY6I88E | 3 | |
| NEOPENTYL GLYCOL DIETHYLHEXANOATE | INACTIVE INGREDIENT | U68ZV6W62C | 3 | |
| NYLON-12 | INACTIVE INGREDIENT | 446U8J075B | 3 | |
| OCTYLDODECYL STEAROYL STEARATE | INACTIVE INGREDIENT | 3D47Q6D93C | 3 | |
| PENTAERYTHRITYL TETRABEHENATE | INACTIVE INGREDIENT | 9MNZ044IRY | 3 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 3 | |
| POLYGLYCERYL-3 DIISOSTEARATE | INACTIVE INGREDIENT | 46P231IQV8 | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 3 | |
| SQUALANE | INACTIVE INGREDIENT | GW89575KF9 | 3 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 3 | |
| TOCOPHEROL | INACTIVE INGREDIENT | R0ZB2556P8 | 3 |
Products#
Every source-derived product name is available through these pages.
- flormar REBORN BB SUNSCREEN BROAD SPECTRUM SPF 30 CP13 Nude Ivory
- OCTINOXATE
- NEOPENTYL GLYCOL DIETHYLHEXANOATE
- ETHYLHEXYL PALMITATE
- HIGH DENSITY POLYETHYLENE
- ISONONYL ISONONANOATE
- OCTYLDODECYL STEAROYL STEARATE
- ALUMINUM STARCH OCTENYLSUCCINATE
- CANDELILLA WAX
- PENTAERYTHRITYL TETRABEHENATE
- ISOCETYL STEAROYL STEARATE
- JOJOBA OIL
- SQUALANE
- NYLON-12
- POLYGLYCERYL-3 DIISOSTEARATE
- CYCLOMETHICONE 5
- ALUMINUM HYDROXIDE
- SILICON DIOXIDE
- STEARIC ACID
- POLYETHYLENE GLYCOL 400
- TOCOPHEROL
- ASCORBYL PALMITATE
- ASCORBIC ACID
- CITRIC ACID MONOHYDRATE
- LINALOOL, (+/-)-
- BUTYLPHENYL METHYLPROPIONAL
- ISOMETHYL-.ALPHA.-IONONE
- .BETA.-CITRONELLOL, (R)-
- BENZYL SALICYLATE
- GERANIOL
- COUMARIN
- TITANIUM DIOXIDE
- FERRIC OXIDE RED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61722-164 | 61722-164-00 |
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 |
|---|---|---|---|---|---|---|
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SWAB / TOPICAL | 5250 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / INTRA-ARTICULAR | ADJ PH | ||
| ALUMINUM HYDROXIDE | ALUMINUM HYDROXIDE | 5QB0T2IUN0 | OINTMENT / TOPICAL | NA | ||
| SQUALANE | SQUALANE | GW89575KF9 | AEROSOL, FOAM / TOPICAL | 2.23 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | LIQUID / INTRAVENOUS | 0.2 %w/v | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | GRANULE, FOR SUSPENSION / ORAL | 113 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / NASAL | 2.8 mg/1ml | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.1 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, DELAYED RELEASE / ORAL | 1190 mg | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | JELLY / VAGINAL | 42.6 %w/w | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | POWDER, FOR SOLUTION / ORAL | 560 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TROCHE / ORAL | 12 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | GEL / TOPICAL | 6300 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | FILM, EXTENDED RELEASE / TRANSDERMAL | 1.38 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 2 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | INJECTION / INTRAMUSCULAR | 192 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, CHEWABLE / ORAL | 7 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, DELAYED RELEASE / ORAL | 80 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | INJECTION, SOLUTION / INFILTRATION | 0.2 %w/v | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | TAPE / TOPICAL | NA | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 0.11 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | DROPS / ORAL | NA | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CONCENTRATE / ORAL | 3000 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE, FOR SOLUTION / ORAL | 1.8 mg/120ml | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / BUCCAL | 3 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAMUSCULAR | 0.05 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TAMPON / VAGINAL | NA | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | EMULSION / TOPICAL | 1.2 %w/w | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / SOFT TISSUE | ADJ PH | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION / INFILTRATION | 0.02 %w/v | ||
| HIGH DENSITY POLYETHYLENE | HIGH DENSITY POLYETHYLENE | UG00KM4WR7 | TABLET, COATED / ORAL | 25 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | DROPS / ORAL | NA | ||
| ALUMINUM HYDROXIDE | ALUMINUM HYDROXIDE | 5QB0T2IUN0 | CAPSULE / ORAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | INJECTION, SOLUTION / SUBCUTANEOUS | 26 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | AEROSOL, POWDER / TOPICAL | NA | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | LOTION / TOPICAL | 5 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SUSPENSION / ORAL | 840 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, DELAYED RELEASE / ORAL | 66 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | POWDER, FOR SOLUTION / ORAL | 315 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SUSPENSION, EXTENDED RELEASE / ORAL | 140.8 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE / ORAL | 13440 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET, EFFERVESCENT / ORAL | 460 mg | ||
| ASCORBYL PALMITATE | ASCORBYL PALMITATE | QN83US2B0N | SUPPOSITORY / RECTAL | 16 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | INJECTION / INTRAMUSCULAR | 406 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | SOLUTION / INTRAVENOUS | 10 mg | ||
| CITRIC ACID MONOHYDRATE | CITRIC ACID MONOHYDRATE | 2968PHW8QP | TABLET / ORAL | 914 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, DELAYED RELEASE / ORAL | 26 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | SYRUP / ORAL | 200 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 |
|---|---|---|---|---|---|---|
| 953116e1-8254-5ac9-e053-2a95a90a54de | a386b28f-02eb-4f82-90b1-d2c42a78bcc0 | 2019-10-18 | Warnings | 953116e1-8254-5ac9-e053-2a95a90a54de a386b28f-02eb-4f82-90b1-d2c42a78bcc0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.