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| Product NDC Code | 72580-109 | ||||
|---|---|---|---|---|---|
| Drug Name | Luxury body ritual hydrating spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Formology Lab Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT ZINC OXIDE 11% SJ_LuxuryBodySPF_Secondary_111423_OL (DFB).jpg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. CHILDREN UNDER 6 MONTHS OF AGE: ASK A DOCTOR. USE A WATER-RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY 2 HOURS. 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Water, Caprylic/Capric Triglyceride, Dimethicone, Butylene Glycol, Sodium Olivate, Silica, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Caprylyl Glycol, Nymphaea Coerulea (Blue Lotus) Flower Extract, Orchis Maculata (Spotted Orchid) Flower Extract, Passiflora Edulis (Passion Fruit) Extract, Camellia Sinensis (Green Tea) Leaf Oil, Potassium Cetyl Phosphate, Stearic Acid, Xylitylglucoside, Anhydroxylitol, Cetearyl Glucoside, Triethoxycaprylylsilane, Xylitol, Tocopheryl Acetate, Xanthan Gum, Caprylhydroxamic Acid, Glycerin, Citric Acid, Pongamia Pinnata Seed Extract
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USE HELPS PREVENT SUNBURN
Purpose
Information about the drug product’s indications for use.PURPOSE SUNSCREEN
Spl product data elements
Usually a list of ingredients in a drug product.LUXURY BODY RITUAL HYDRATING SPF 30 ZINC OXIDE SODIUM OLIVATE DACTYLORHIZA MACULATA FLOWER NYMPHAEA CAERULEA FLOWER SORBITAN OLIVATE BUTYLENE GLYCOL WATER MEDIUM-CHAIN TRIGLYCERIDES DIMETHICONE CETOSTEARYL ALCOHOL .ALPHA.-TOCOPHEROL ACETATE CETEARYL OLIVATE CETEARYL GLUCOSIDE XANTHAN GUM GREEN TEA LEAF TRIETHOXYCAPRYLYLSILANE ZINC OXIDE ZINC OXIDE CAPRYLYL GLYCOL STEARIC ACID XYLITOL XYLITYLGLUCOSIDE ANHYDROXYLITOL PASSIFLORA EDULIS FRUIT SILICON DIOXIDE POTASSIUM CETYL PHOSPHATE GLYCERIN CAPRYLHYDROXAMIC ACID
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.SJ_LuxuryBodySPF_Secondary_111423_OL (PDP).jpg
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.DO NOT USE ON DAMAGED OR BROKEN SKIN.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN . IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.STOP USE AND ASK A DOCTOR IF RASH OCCURS.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API