Indications and uses
Helps prevent sunburn Higher SPF gives more sunburn protection Provides moderate protection against sunburn
LBEL
- Manufacturer
- Ventura Corporation Ltd. (San Juan, P.R) | Bel Star, S.A. | Yobel Supply Chain Management S.A.
- Effective date
- 2011-09-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:50:51
Label at a glance#
ProductLBEL Hydra Calme SPF 15
Active ingredientOctinoxate, Octisalate, Oxybenzone
Label structure9 sections
Dosage and administration
Apply smoothly every morning before sun exposure and as needed. Use in the morning after cleansing and toning. Apply small amounts using the fingertips and spreading with upward, circular movements. Rub gently until absorbed completely. Children under 6 months of age: ask a doctor. Moderate sun protection product
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active Ingredient | Purpose |
|---|---|
| Octinoxate 7.5% | Sunscreen |
| Octisalate 4.0 % | Sunscreen |
| Oxybenzone 4.0%, | Sunscreen |
Uses
- Helps prevent sunburn
- Higher SPF gives more sunburn protection
- Provides moderate protection against sunburn
Warnings
For external use only
When using this product
- Keep out of eyes. Rinse with water to remove
Stop use and ask a doctor if
- Rash or irritation develops and lasts
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply smoothly every morning before sun exposure and as needed.
- Use in the morning after cleansing and toning. Apply small amounts using the fingertips and spreading with upward, circular movements. Rub gently until absorbed completely.
- Children under 6 months of age: ask a doctor.
- Moderate sun protection product
Other information
- Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreen may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.
Inactive ingredients
aqua (water), c12-15 alkyl benzoate, pisum sativum extract (pisum sativum (pea) extract), cyclohexasiloxane, dimethicone, butylene glycol, cetearyl alcohol, erythritol, hdi/trimethylol hexyllactone crosspolymer, phenoxyethanol, sodium acrylate/ acryloyldimethyltaurate/ dimethylacrylamide crosspolymer, c20-22 alkyl phosphate, glyceryl stearate, hydroxyethyl acrylate/ sodium acryloyldimethyl taurate copolymer, propylene glycol, c20-22 alcohols, triethanolamine, isohexadecane, methylparaben, parfum (fragrance), c14-22 alcohols, cetearyl glucoside, butylparaben, cyclopentasiloxane, chlorphenesin, xanthan gum, propylparaben, acrylates/ c10-30 alkyl acrylate crosspolymer, disodium edta, sorbic acid, polysorbate 60, c12-20 alkyl glucoside, glycerin, hydrolyzed algin, ethylparaben, chlorella vulgaris extract, maris aqua (sea water), isobutylparaben, silica, homarine hcl, rubus chamaemorus fruit extract
SPL UNCLASSIFIED SECTION
P.R.: Dist by Ventura Corporation, Ltd. San Juan, Puerto Rico 00926.
PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton
L'BEL
HYDRA CALME
SPF15
Intensive moisturizing
face lotion with SPF 15
50 ml e (1.6 fl.oz.)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 13537-031-02 | 2025-02-20 | C162847 | 48780-1 | 960f7f55-c7cd-8e05-e053-dbdaa90a074a | L'BEL HYDRA CALME |
| 13537-031-04 | 2025-02-20 | C162847 | 48780-1 | 960f7f55-c7cd-8e05-e053-dbdaa90a074a | L'BEL HYDRA CALME |
| 13537-031-05 | 2025-02-20 | C162847 | 48780-1 | 960f7f55-c7cd-8e05-e053-dbdaa90a074a | L'BEL HYDRA CALME |
| 13537-031-02 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c7cd-8e05-e053-dbdaa90a074a | L'BEL HYDRA CALME |
| 13537-031-04 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c7cd-8e05-e053-dbdaa90a074a | L'BEL HYDRA CALME |
| 13537-031-05 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c7cd-8e05-e053-dbdaa90a074a | L'BEL HYDRA CALME |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Octinoxate | ACTIVE INGREDIENT | 4Y5P7MUD51 | 1 | |
| Octisalate | ACTIVE INGREDIENT | 4X49Y0596W | 1 | |
| Oxybenzone | ACTIVE INGREDIENT | 95OOS7VE0Y | 1 | |
| Octinoxate | ACTIVE MOIETY | 4Y5P7MUD51 | 1 | |
| Octisalate | ACTIVE MOIETY | 4X49Y0596W | 1 | |
| Oxybenzone | ACTIVE MOIETY | 95OOS7VE0Y | 1 | |
| alkyl (c12-15) benzoate | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| butylene glycol | INACTIVE INGREDIENT | 3XUS85K0RA | 1 | |
| butylparaben | INACTIVE INGREDIENT | 3QPI1U3FV8 | 1 | |
| c12-20 alkyl glucoside | INACTIVE INGREDIENT | K67N5Z1RUA | 1 | |
| c14-22 alcohols | INACTIVE INGREDIENT | B1K89384RJ | 1 | |
| c20-22 alcohols | INACTIVE INGREDIENT | O4M0347C6A | 1 | |
| c20-22 alkyl phosphate | INACTIVE INGREDIENT | L4VKP0Y7RP | 1 | |
| cetearyl glucoside | INACTIVE INGREDIENT | 09FUA47KNA | 1 | |
| cetostearyl alcohol | INACTIVE INGREDIENT | 2DMT128M1S | 1 | |
| chlorella vulgaris | INACTIVE INGREDIENT | RYQ4R60M02 | 1 | |
| chlorphenesin | INACTIVE INGREDIENT | I670DAL4SZ | 1 | |
| cyclomethicone 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| cyclomethicone 6 | INACTIVE INGREDIENT | XHK3U310BA | 1 | |
| dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| erythritol | INACTIVE INGREDIENT | RA96B954X6 | 1 | |
| ethylparaben | INACTIVE INGREDIENT | 14255EXE39 | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| glyceryl monostearate | INACTIVE INGREDIENT | 230OU9XXE4 | 1 | |
| isobutylparaben | INACTIVE INGREDIENT | 0QQJ25X58G | 1 | |
| isohexadecane | INACTIVE INGREDIENT | 918X1OUF1E | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| pea | INACTIVE INGREDIENT | W4X7H8GYFM | 1 | |
| phenoxyethanol | INACTIVE INGREDIENT | HIE492ZZ3T | 1 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| propylparaben | INACTIVE INGREDIENT | Z8IX2SC1OH | 1 | |
| rubus chamaemorus fruit | INACTIVE INGREDIENT | 74CW8G72Q6 | 1 | |
| silicon dioxide | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| sorbic acid | INACTIVE INGREDIENT | X045WJ989B | 1 | |
| trolamine | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| xanthan gum | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- LBEL Hydra Calme SPF 15
- Octinoxate, Octisalate, and Oxybenzone
- Octinoxate
- Octisalate
- Oxybenzone
- water
- alkyl (c12-15) benzoate
- pea
- cyclomethicone 6
- dimethicone
- butylene glycol
- cetostearyl alcohol
- erythritol
- phenoxyethanol
- c20-22 alkyl phosphate
- glyceryl monostearate
- propylene glycol
- c20-22 alcohols
- trolamine
- isohexadecane
- methylparaben
- c14-22 alcohols
- cetearyl glucoside
- butylparaben
- cyclomethicone 5
- chlorphenesin
- xanthan gum
- propylparaben
- edetate disodium
- sorbic acid
- polysorbate 60
- c12-20 alkyl glucoside
- glycerin
- ethylparaben
- chlorella vulgaris
- isobutylparaben
- silicon dioxide
- rubus chamaemorus fruit
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 13537-031 | 13537-031-01, 13537-031-02, 13537-031-03, 13537-031-04, 13537-031-05 |
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 |
|---|---|---|---|---|---|---|
| methylparaben | METHYLPARABEN | A2I8C7HI9T | POWDER / ORAL | NA | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | SPRAY / TOPICAL | 1 %w/w | ||
| butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | SYRUP / ORAL | 28.4 mg/1ml | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / NASAL | 100 mg/100ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAVENOUS | 7 mg | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | LOTION / TOPICAL | 5 %w/w | ||
| glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | CREAM / VAGINAL | 6 mg | ||
| trolamine | TROLAMINE | 9O3K93S3TK | DROPS / NASAL | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET / SUBLINGUAL | 1.23 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | SOLUTION / RECTAL | 0.01 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| cyclomethicone 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL / TOPICAL | 2.5 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | TABLET, COATED / ORAL | 0.8 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SPRAY / TOPICAL | 0.2 %w/w | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / RESPIRATORY (INHALATION) | 43 mg | ||
| glyceryl monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| trolamine | TROLAMINE | 9O3K93S3TK | SOLUTION / TOPICAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SOLUTION / ORAL | 13 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | GEL / TOPICAL | 24 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | SYRUP / ORAL | 40 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | LIQUID / ORAL | 0.5 mg/1ml | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / RESPIRATORY (INHALATION) | NA | ||
| trolamine | TROLAMINE | 9O3K93S3TK | SOAP / TOPICAL | 0.08 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| sorbic acid | SORBIC ACID | X045WJ989B | LOTION / TOPICAL | 4 mg | ||
| cetostearyl alcohol | CETOSTEARYL ALCOHOL | 2DMT128M1S | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| butylene glycol | BUTYLENE GLYCOL | 3XUS85K0RA | SYSTEM / TRANSDERMAL | 8.12 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | GRANULE / ORAL | 5000 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAMUSCULAR | 4000 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, COATED / ORAL | 0.21 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAVENOUS | 95 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | CREAM / TOPICAL | 46 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / AURICULAR (OTIC) | 25 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, FILM COATED / ORAL | 1.55 mg | ||
| butylparaben | BUTYLPARABEN | 3QPI1U3FV8 | DROPS / ORAL | NA | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | POWDER / ORAL | 602 mg | ||
| xanthan gum | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SOLUTION / ORAL | 10 mg/5ml | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / OPHTHALMIC | 0.05 %w/w | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 2 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| edetate disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, COATED / ORAL | 14.21 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / INTRAMUSCULAR | 0.02 %w/v | ||
| polysorbate 60 | POLYSORBATE 60 | CAL22UVI4M | SUPPOSITORY / VAGINAL | 0.03 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | CONCENTRATE / ORAL | 12 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SOLUTION / NASAL | 250 mg | ||
| silicon dioxide | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET, FOR SUSPENSION / ORAL | 220 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | CREAM / TOPICAL | 6 mg | ||
| propylparaben | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRA-ARTICULAR | 0.03 %w/v |
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 |
|---|---|---|---|---|---|---|
| 2e9aae8f-97ba-d6d2-e063-6394a90a2c37 | 25cb3da7-9cf6-4031-9d4e-a4c710254859 | 2025-02-20 | Warnings | 25cb3da7-9cf6-4031-9d4e-a4c710254859 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.