CALM IT DOWN KIT
- Manufacturer
- mybody
- Effective date
- 2014-06-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:39:39
Label at a glance#
ProductCALM IT DOWN KIT
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure13 sections
Contacts and useful links#
Websitewww.lovemybody.com
WWW.LOVEMYBODY.COM
WWW.LOVEMYBODY.COMLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENT
TITANIUM DIOXIDE 10.9%
ZINC OXIDE 4.01%
OTC - PURPOSE SECTION
PURPOSE
SUNSCREEN
INDICATIONS & USAGE SECTION
USE HELPS PROTECT AGAINST SUNBURN
WARNINGS SECTION
WARNINGS
FOR EXTERNAL USE ONLY
OTC - WHEN USING SECTION
WHEN USING THIS PRODUCT
- AVOID CONTACT WITH EYES. IF PRODUCT GETS INTO EYES, RINSE THOROUGHLY WITH WATER.
OTC - STOP USE SECTION
- 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.
OTC - DO NOT USE SECTION
DO NOT USE
- ON INFLAMED OR BROKEN SKIN.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS
USE AM. APPLY AS NEEDED TO FACE AND NECK AREA. CAN ALSO BE APPLIED TO THE EARS, HANDS AND DECOLETAGE. APPLY EVENLY 15-30 MINUTES BEFORE SUN EXPOSURE AND AS NEEDED. REAPPLY AS NEEDED OR AFTER SWIMMING OR PERSPIRING. FOR BEST RESULTS
- CLEANSE SKIN THOROUGHLY BEFORE APPLYING.
- APPLY LIBERALLY TO FACE AND NECK BEFORE SUN EXPOSURE.
- USE ALONE OR UNDER MAKE-UP.
- CHILDREN UNDER 6 MONTHS OF AGE, ASK A DOCTOR.
OTHER SAFETY INFORMATION
OTHER INFORMATION
- STORE AT ROOM TEMPERATURE
- AVOID HIGH TEMPERATURES AND PROTECT FROM FREEZING.
- DO NOT USE IF INNER SEAL IS BROKEN.
SUN ALERT
LIMITING SUN EXPOSURE, WEARING PRODUCTIVE CLOTHING, AND USING SUNSCREEN MAY REDUCE THE RISKS OF SKIN AGING, SKIN CANCER AND OTHER HARMFUL EFFECTS OF THE SUN.
INACTIVE INGREDIENT SECTION
INACTIVE INGREDIENTS: CYCLOPENTASILOXANE, CYCLOMETHICONE, DIMETHICONE CROSSPOLYMER, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER, SORBITAN ISOSTEARATE, TRIBEHENIN, CALCIUM BEHENATE, MELANIN, DIMETHICONOL, ALUMINA, PEG-10 DIMETHICONE, METHICONE, IRON OXIDES, CHOLECALCIFEROL, LYCOPENE, GLYCERIN, SUCROSE PALMITATE, LECITHIN.
OTC - QUESTIONS SECTION
QUESTIONS OR COMMENTS?
CALL 877.423.1314 * www.LOVEMYBODY.COM
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49520-502-64 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4e39-60a7-e053-dbdaa90a05bd | 0430bf68-ee36-4762-a245-ec280cb480a5 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49520-502-64 | CALM IT DOWN KIT | 1 in 1 KIT | KIT | 1 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| TITANIUM DIOXIDE | ACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| ZINC OXIDE | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| TITANIUM DIOXIDE | ACTIVE MOIETY | 15FIX9V2JP | 1 | |
| ZINC OXIDE | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | 1 | |
| CALCIUM BEHENATE | INACTIVE INGREDIENT | J5VFA9V6YG | 1 | |
| CHOLECALCIFEROL | INACTIVE INGREDIENT | 1C6V77QF41 | 1 | |
| CYCLOMETHICONE | INACTIVE INGREDIENT | NMQ347994Z | 1 | |
| CYCLOMETHICONE 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) | INACTIVE INGREDIENT | 9E4CO0W6C5 | 1 | |
| DIMETHICONOL (41 MPA.S) | INACTIVE INGREDIENT | 343C7U75XW | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| LECITHIN, SOYBEAN | INACTIVE INGREDIENT | 1DI56QDM62 | 1 | |
| LYCOPENE | INACTIVE INGREDIENT | SB0N2N0WV6 | 1 | |
| MELANIN SYNTHETIC (TYROSINE, PEROXIDE) | INACTIVE INGREDIENT | O0CV1RMR44 | 1 | |
| METHICONE (20 CST) | INACTIVE INGREDIENT | 6777U11MKT | 1 | |
| METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER | INACTIVE INGREDIENT | EG97988M5Q | 1 | |
| PEG-10 DIMETHICONE (600 CST) | INACTIVE INGREDIENT | 8PR7V1SVM0 | 1 | |
| SORBITAN ISOSTEARATE | INACTIVE INGREDIENT | 01S2G2C1E4 | 1 | |
| SUCROSE PALMITATE | INACTIVE INGREDIENT | 3OSQ643ZK5 | 1 | |
| TRIBEHENIN | INACTIVE INGREDIENT | 8OC9U7TQZ0 | 1 |
Products#
Every source-derived product name is available through these pages.
- CALM IT DOWN KIT
- TITANIUM DIOXIDE, ZINC OXIDE
- PROTECT AND SERVE TINTED SUN SHIELD SPF 30
- TITANIUM DIOXIDE AND ZINC OXIDE
- TITANIUM DIOXIDE
- ZINC OXIDE
- CYCLOMETHICONE 5
- CYCLOMETHICONE
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER
- SORBITAN ISOSTEARATE
- TRIBEHENIN
- CALCIUM BEHENATE
- MELANIN SYNTHETIC (TYROSINE, PEROXIDE)
- DIMETHICONOL (41 MPA.S)
- ALUMINUM OXIDE
- PEG-10 DIMETHICONE (600 CST)
- METHICONE (20 CST)
- FERRIC OXIDE RED
- CHOLECALCIFEROL
- LYCOPENE
- GLYCERIN
- SUCROSE PALMITATE
- LECITHIN, SOYBEAN
- CLEAN ROUTINE
- WATER
- SODIUM COCOYL GLUTAMATE
- COCO-BETAINE
- MYRISTOYL PENTAPEPTIDE-4
- CURDLAN
- .ALPHA.-TOCOPHEROL ACETATE
- ALOE VERA LEAF
- LIME JUICE
- COCONUT ACID
- SAFFLOWER ACID
- CITRIC ACID MONOHYDRATE
- GLYCERYL LAURATE
- LAURIC ACID
- GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)
- SUCROSE COCOATE
NDC Codes#
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 |
|---|---|---|---|---|---|---|
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SUSPENSION / SUBCUTANEOUS | 1.6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / NASAL | 25 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / TOPICAL | 2.5 %w/w | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | CREAM, AUGMENTED / TOPICAL | 260 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | POWDER, FOR SUSPENSION / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRAVENOUS | 33750 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| CYCLOMETHICONE 5 | CYCLOMETHICONE 5 | 0THT5PCI0R | AEROSOL / TOPICAL | 2.5 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / TRANSDERMAL | 306.2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | DROPS / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPRAY / NASAL | 22.3 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL / TOPICAL | 3 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 3.6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, COATED / ORAL | 1 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, COATED / ORAL | 0.12 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE / ORAL | 5 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, EXTENDED RELEASE / ORAL | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| SUCROSE PALMITATE | SUCROSE PALMITATE | 3OSQ643ZK5 | TABLET / ORAL | 1.25 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / TOPICAL | 18144 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, CHEWABLE / ORAL | 12 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, CHEWABLE / ORAL | 2 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | CAPSULE, EXTENDED RELEASE / ORAL | 5 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / ORAL | 8 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION, EXTENDED RELEASE / ORAL | 2000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | TABLET, FILM COATED / ORAL | 0.33 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GEL / TOPICAL | 500 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 225 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / NASAL | 10 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DROPS / ORAL | 300 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | CREAM / VAGINAL | 1 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / BUCCAL | 0.4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, EMULSION / INTRAVENOUS | 24100 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| FERRIC OXIDE RED | FERRIC OXIDE RED | 1K09F3G675 | TABLET / SUBLINGUAL | 1 mg | ||
| LECITHIN, SOYBEAN | SOYBEAN LECITHIN | 1DI56QDM62 | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.1 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / RECTAL | 440 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 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 |
|---|---|---|---|---|---|---|
| 10847989-96c6-427a-82d3-1ac9121c4beb | 0430bf68-ee36-4762-a245-ec280cb480a5 | 2014-06-30 | Warnings | 10847989-96c6-427a-82d3-1ac9121c4beb 0430bf68-ee36-4762-a245-ec280cb480a5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.