Ultra Protection Stick Broad Spectrum Spf 40
FDA Label NDC 68807-309

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Temmentec Ag for the product Ultra Protection Stick Broad Spectrum Spf 40 (NDC 68807-309). 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 active ingredients      purpose, uses, warning, indications, warnings, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients      Purpose

Avobenzone 3%       Sunscreen

Homosalate 7%        Sunscreen

Octisalate 5%           Sunscreen

Oxybenzone 2%       Sunscreen

Uses

helps prevent sunburn

Warning

Keep out of reach of children

Indications

Stop use and ask a doctor if rash occurs

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.

Directions

 apply daily after cleansing and toning

 apply liberally 15 minutes befor e sun exposure

 children under 6 months of age: Ask a doctor

 reapply at least every 2 hours

 use a water resistant sunscreen if swimming or sweating

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-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredients

Polyethylene, Petrolatum, C12-15 Alkyl Benzoate, Caprylyl Methicone, Aluminum Starch Octenylsuccinate, Butyloctyl Salicylate, Polyester-8, Simmondsia Chinensis (Jojoba) Butter, Water (Aqua), ButyrospermumParkii (Shea Butter), Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Beeswax (Cera Alba), VP/Eicosene Copolymer, Pelvetia Canaliculata Extract, Sodium Lactate, Palmaria Palmata Extract, Behenyl Olivate, Lecithin, Porphyra Umbilicalis Extract, Ammonium Glycyrrhizate, Algae Extract, Benzylidene Dimethoxydimethylindanone, Dipropylene Glycol, BHT, Alcohol, Butylene Glycol, Phenoxyethanol

Package Label.Principal Display Panel

Carton (Carton)

Carton (Carton)

Stick (Stick)

Stick (Stick)

Ultra Protection Stick

Eye - Lip -  Nose

Sunscreen Broad Spectrum


Stick Solaire Haute Protection

Yeux - Levres - Nez

Creme Solaire

Large Spectre

SPF 40

la prarie Switzerland

10 g/ Net Wt. 0.35 OZ

Made in Switzerland Fabrique en Suisse

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