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Babo botanicals spf 30 daily sheer tinted sunscreen - natural glow - Medication Information

Product NDC Code 79265-8072
Drug Name

Babo botanicals spf 30 daily sheer tinted sunscreen - natural glow

Type Brand
Active Ingredients
Titanium dioxide 3000 mg/100ml
Zinc oxide 3000 mg/100ml
Route TOPICAL
Dosage Form LOTION
Application Number part352
Labeler Name Babo Botanicals, Inc.
Packages
Package NDC Code Description
79265-8072-0 1 tube in 1 box (79265-8072-0) / 50 ml in 1 tube (79265-8072-1)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient(s) Zinc Oxide 6% Purpose: Sunscreen Titanium Dioxide 6% Purpose: Sunscreen

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 liberally15 minutes before sun exposure. Children under 6 months of age: Ask a doctor. • use a water resistant sunscreen if swimming or sweating• reapply: • immediately after towel drying • at least every 2 hours Sun Protection Measures Sun exposure increases risk of skin cancer and early skin aging. To decrease 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 10a.m. - 2p.m. Wear long sleeved shirts, pants, hats and sunglasses.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Aloe Barbadensis Leaf (Aloe Vera Gel) Juice*, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Beeswax*, Butyrospermum Parkii (Shea) Butter*, C13-14 Alkyls Benzoate, Camellia Sinensis (Green Tea) Extract*, Caryodendron Orinocense (Kahai) Oil, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil*, Cucumis Sativus (Cucumber) Extract, Decyl Glucoside, Glycerin*, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil*, Hippophae Rhamnoides (Sea Buckthorn) Oil, Hyaluronic Acid, Iron Oxides, Lecithin, Mangifera Indica (Mango) Butter, Punica Granatum (Pomegranate) Extract*, Rosmarinus Officinalis (Rosemary) Oil*, Saccharide Isomerate, Sodium Polyacrylate, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol. *Certified Organic ingredients

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 Uses • 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.
Babo Botanicals SPF 30 Daily Sheer Tinted Sunscreen - Natural Glow Mineral Sunscreen WATER GREEN TEA LEAF ROSEMARY XANTHAN GUM PROPANEDIOL YELLOW WAX SHEA BUTTER ALKYL (C12-15) BENZOATE CARYODENDRON ORINOCENSE WHOLE MEDIUM-CHAIN TRIGLYCERIDES GLYCERYL STEARATE CITRATE COCONUT OIL CUCUMBER SEED GLYCERIN GLYCERYL 1-UNDECYLENATE ALOE VERA LEAF DECYL GLUCOSIDE FERRIC OXIDE RED LECITHIN, SUNFLOWER MANGO SACCHARIDE ISOMERATE STEARIC ACID ALPHA-TOCOPHEROL SODIUM POLYACRYLATE (8000 MW) GLYCERYL CAPRYLATE ARGAN OIL GLYCERYL MONOSTEARATE SUNFLOWER OIL HYALURONIC ACID HIPPOPHAE RHAMNOIDES SEED OIL POMEGRANATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE

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.
Package Label - Principal Display Panel 50 mL NDC: 79265-8072-1 Outer packaging 8072

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.
This is a sunscreen manufactured according to the 2009 Final Monograph The sunscreen is manufactured using only approved mineral active ingredients of Zinc Oxide (6%) and Titanium Oxide (6%) in the preparation of the product (percentage in final product formulation) consistent with The Final Monograph.

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 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.
Keep out of eyes. Rinse with water to remove.

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