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 FOUNDATION CREAM SUNSCREEN BROAD SPECTRUM SPF 20 SF30 Caramel
- Manufacturer
- Kosan Kozmetik Sanayi ve Ticaret A.S.
- Effective date
- 2019-10-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:00:51
Label at a glance#
Productflormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF30 Caramel
Active ingredientOCTINOXATE
Label structure7 sections
Dosage and administration
Shake well before use. Apply drop by drop with fingertips. 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 pro...
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 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 swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Shake well before use.
- Apply drop by drop with fingertips.
- 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
water, cyclopentasiloxane, butylene glycol, cetyl PEG/PPG-10/1 dimethicone, dimethicone, PEG-10 dimethicone, propanediol, polysilicone-11, glycerin, SD alcohol 40-B, dimethicone/vinyl dimethicone crosspolymer, phenoxyethanol, disteardimonium hectorite, trimethylsiloxysilicate, methyl methacrylate crosspolymer, sodium chloride, triethoxycaprylysilane, aluminum hydroxide, sodium PCA, ethylhexylglycerin, fragrance, urea, Anogeissus leiocarpus bark extract, algae extract, soluble collagen, silica, laureth-12, trehalose, leuconostoc/radish root ferment filtrate, polyquaternium-51, sodium hyaluronate, chlorphenesin, propylene glycol, fig (Ficus carica) fruit extract, cotton (Gossypium hirsutum) seed extract, linseed (Linumusitatissium) seed extract, sodium dehydroacetate, caprylyl glycol, hexyl cinnamal, benzyl salicylate, butylphenyl methylpropional, alpha-isomethylionone, linalool, titanium dioxide, iron oxides.
Product Labels
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61722-210-00 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-5c0d-a910-e053-dadaa90a0b85 | flormar REBORN FOUNDATION CREAM SUNSCREEN BROAD SPECTRUM SPF 20 SF30 Caramel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61722-210-00 | flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF30 Caramel | 1 in 1 BOX | CREAM | 1 | 3 | |
| 61722-210-00 | flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF30 Caramel | 30 mL in 1 BOTTLE | CREAM | 30 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61722-210 | FLORMAR REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF30 CARAMEL (OCTINOXATE) CREAM [KOSAN KOZMETIK SANAYI VE TICARET A.S.] | 3 | Legacy NDC, 2 package rows | 20191019_043b1d97-458f-4a2a-b14d-753988ce9e68.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| OCTINOXATE | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| OCTINOXATE | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| .ALPHA.-HEXYLCINNAMALDEHYDE | INACTIVE INGREDIENT | 7X6O37OK2I | 1 | |
| ALUMINUM HYDROXIDE | INACTIVE INGREDIENT | 5QB0T2IUN0 | 1 | |
| ANOGEISSUS LEIOCARPUS BARK | INACTIVE INGREDIENT | U5TP1X38RH | 1 | |
| BENZYL SALICYLATE | INACTIVE INGREDIENT | WAO5MNK9TU | 1 | |
| BUTYLENE GLYCOL | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| BUTYLPHENYL METHYLPROPIONAL | INACTIVE INGREDIENT | T7540GJV69 | 1 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| CHLORPHENESIN | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| COTTON SEED | INACTIVE INGREDIENT | DI0ZRJ0MXN | 1 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| DISTEARDIMONIUM HECTORITE | INACTIVE INGREDIENT | X687XDK09L | 1 | |
| ETHYLHEXYLGLYCERIN | INACTIVE INGREDIENT | 147D247K3P | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| FLAX SEED | INACTIVE INGREDIENT | 4110YT348C | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| HYALURONATE SODIUM | INACTIVE INGREDIENT | YSE9PPT4TH | 1 | |
| ISOMETHYL-.ALPHA.-IONONE | INACTIVE INGREDIENT | 9XP4LC555B | 1 | |
| LAURETH-12 | INACTIVE INGREDIENT | OAH19558U1 | 1 | |
| LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE | INACTIVE INGREDIENT | D2QHA03458 | 1 | |
| LINALOOL, (+/-)- | INACTIVE INGREDIENT | D81QY6I88E | 1 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| PROPANEDIOL | INACTIVE INGREDIENT | 5965N8W85T | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| SODIUM DEHYDROACETATE | INACTIVE INGREDIENT | 8W46YN971G | 1 | |
| SODIUM PYRROLIDONE CARBOXYLATE | INACTIVE INGREDIENT | 469OTG57A2 | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| TREHALOSE | INACTIVE INGREDIENT | B8WCK70T7I | 1 | |
| TRIETHOXYCAPRYLYLSILANE | INACTIVE INGREDIENT | LDC331P08E | 1 | |
| UREA | INACTIVE INGREDIENT | 8W8T17847W | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- flormar REBORN FOUNDATION SUNSCREEN BROAD SPECTRUM SPF 20 SF30 Caramel
- OCTINOXATE
- WATER
- CYCLOMETHICONE 5
- BUTYLENE GLYCOL
- DIMETHICONE
- PROPANEDIOL
- GLYCERIN
- PHENOXYETHANOL
- DISTEARDIMONIUM HECTORITE
- SODIUM CHLORIDE
- TRIETHOXYCAPRYLYLSILANE
- ALUMINUM HYDROXIDE
- SODIUM PYRROLIDONE CARBOXYLATE
- ETHYLHEXYLGLYCERIN
- UREA
- ANOGEISSUS LEIOCARPUS BARK
- SILICON DIOXIDE
- LAURETH-12
- TREHALOSE
- LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE
- HYALURONATE SODIUM
- CHLORPHENESIN
- PROPYLENE GLYCOL
- COTTON SEED
- FLAX SEED
- SODIUM DEHYDROACETATE
- CAPRYLYL GLYCOL
- .ALPHA.-HEXYLCINNAMALDEHYDE
- BENZYL SALICYLATE
- BUTYLPHENYL METHYLPROPIONAL
- ISOMETHYL-.ALPHA.-IONONE
- LINALOOL, (+/-)-
- TITANIUM DIOXIDE
- FERRIC OXIDE RED
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61722-210 | 61722-210-00 |
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 |
|---|---|---|---|---|---|---|
| UREA | UREA | 8W8T17847W | TABLET, EXTENDED RELEASE / ORAL | 0.01 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / RECTAL | NA | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / INTRAMUSCULAR | 17 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / INTRAVENOUS | 2916 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GUM, CHEWING / BUCCAL | 182 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBMUCOSAL | 16 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | CAPSULE, COATED PELLETS / ORAL | 69 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / SOFT TISSUE | 26 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / RESPIRATORY (INHALATION) | 43 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | CAPSULE / ORAL | 6 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / RECTAL | 90400 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 0.86 %w/v | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | INSERT / VAGINAL | 8 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FILM COATED / ORAL | 166 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRATHECAL | 1.35 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / RETROBULBAR | 648 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / SUBLINGUAL | 10 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAVASCULAR | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / SUBCUTANEOUS | 1486 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / INTRAMUSCULAR | 90 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / ORAL | 750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CONCENTRATE / ORAL | 1800 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / EPIDURAL | 0.9 %w/v | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | LIQUID / INTRAVENOUS | 6320 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAMUSCULAR | 1486 mg | ||
| SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | PELLET / ORAL | 34 mg | ||
| ALUMINUM HYDROXIDE | ALUMINUM HYDROXIDE | 5QB0T2IUN0 | CAPSULE / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY, METERED / NASAL | 13 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | PASTE / DENTAL | 0.5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PERIDURAL | 8.07 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / OPHTHALMIC | 13 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| HYALURONATE SODIUM | HYALURONATE SODIUM | YSE9PPT4TH | LOTION / TOPICAL | 0.01 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRAVITREAL | 6 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 |
|---|---|---|---|---|---|---|
| 9530ff74-05c0-1117-e053-2a95a90a5472 | 043b1d97-458f-4a2a-b14d-753988ce9e68 | 2019-10-18 | Warnings | 9530ff74-05c0-1117-e053-2a95a90a5472 043b1d97-458f-4a2a-b14d-753988ce9e68 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.