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| Product NDC Code | 51785-922 | ||||
|---|---|---|---|---|---|
| Drug Name | Herbalife herbal aloe face and body mineral sunscreen broad spectrum spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part352 | ||||
| Labeler Name | Herbalife International of America, Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc Oxide (19.24%)
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 • Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours • Children under 6 months: Ask a doctor • 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 (Aqua), Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Dimethicone, Glycerin, Cetearyl Olivate, Sorbitan Olivate, VP/Eicosene Copolymer, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, Tocopheryl Acetate, Triethoxycaprylylsilane, Cetearyl Alcohol, Polyhydroxystearic Acid, Xanthan Gum, Fragrance (Parfum), Disodium EDTA, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol, Phenoxyethanol.
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.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
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.Herbalife Herbal Aloe Face and Body Mineral Sunscreen Broad Spectrum SPF 30 Zinc Oxide SORBITAN OLIVATE ALPHA-TOCOPHEROL ACETATE EDETATE DISODIUM GLYCERIN SHEA BUTTER XANTHAN GUM ETHYLHEXYLGLYCERIN CAPRYLYL GLYCOL WATER MEDIUM-CHAIN TRIGLYCERIDES POLYHYDROXYSTEARIC ACID (2300 MW) ALOE VERA LEAF BUTYLOCTYL SALICYLATE CETOSTEARYL ALCOHOL DIMETHICONE 350 ZINC OXIDE ZINC OXIDE CETEARYL OLIVATE PHENOXYETHANOL VINYLPYRROLIDONE/EICOSENE COPOLYMER TRIETHOXYCAPRYLYLSILANE HEXYLENE GLYCOL
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.HERBAL ALOE FACE & BODY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 SUNSCREEN LOTION SPF 30 SWEAT & WATER RESISTANT (40 MINUTES) NOT FORMULATED WITH OXYBENZONE OR OCTOCRYLENE 4 fl oz (120 ml) Product Image
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Distributed by: Herbalife International of America, Inc. 800 W. Olympic Blvd., Suite 406 Los Angeles, CA 90015, USA Made in USA with US and imported ingredients. CUT0921NA0A-00 ©2021 HERBALIFE NUTRITION
HERBAL ALOE FOR EVERY BODY, EVERY DAY PROTECTS SKIN FROM SUN’S DAMAGING UVA/UVB RAYS NO ADDED PARABENS • INCLUDES BOTANICALS Protect your skin with this broad spectrum sunscreen that is sweat and water resistant (40 minutes). Formulated with aloe to hydrate the skin, leaving it feeling soft and smooth. Pamper your skin and hair with our entire Herbal Aloe line: • Strengthening Shampoo • Strengthening Conditioner • Hand & Body Wash • Hand & Body Cream • Soothing Aloe Gel • Bath & Body Bar The Skin Cancer Foundation recommends this product as an effective broad spectrum sunscreen.
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 sunlight
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
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