Botao Baby Mineral Sunscreen L Lotion
FDA Label NDC 69435-1504

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Peer Pharm Ltd. for the product Botao Baby Mineral Sunscreen L (NDC 69435-1504). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients(in each 30 ml), purpose, uses, warnings, do not use, when using this product,, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients(In Each 30 Ml)

Zinc Oxide 24.5%

Purpose

Sunscreen

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.

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 or irritation develops and lasts.

Keep Out Of Reach Of Children.

If swallowed, call a poison control center or get medical help right  away.

Directions

shake well before each use

spray liberally and spread evenly by hand 15 minutes before sun exposure

hold4 to 6 inches from the skin to apply

do not spray directly into face.

Spray on hands then apply to face

do not apply in windy conditions

Use in a well-ventilated area

reapply: after 40 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

Inactive Ingredients

Water,Coco-Caprylate, Styrene/Acrylates Copolymer,Butane,Isobutane, Propane, Octlydodecyl Citrate Crosspolymer,Cetearyl Olivate, Sorbitan Olivate, Caprylyl Glycol, Glycerin, Polyhydroxystearic acid, Aloe Barbadensis Leaf Juice, Panthenol, Triethoxycapryllsilane, Cetearyl Alcohol,Tocopherol, Butyrosperum Parkii (Shea) Butter,Silica, Silica Dimethyl Silyate , Xanthan Gum, Caprylhydroxamix Acid, Propanediol, Sodium Phytate, Dipotassium Glycyrrhizate, Chamomilla Recutita, (Matricaria) Flower Extract ,Calendula Officianlis Flower Extract,Citric Acid

Other Information

  • Store in room temparture
  • protect from freezing
  • may stain clothing

Package Labeling

Box (33373 Botao Baby Lotion Box Fda 06)

Box (33373 Botao Baby Lotion Box Fda 06)

Tube (33373 Botao Baby Lotion Tube Fda 08)

Tube (33373 Botao Baby Lotion Tube Fda 08)

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