Botanics Daily Hand Therapy Sunscreen Spf 10
FDA Label NDC 68472-049

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Boots Retail Usa Inc for the product Botanics Daily Hand Therapy Sunscreen Spf 10 (NDC 68472-049). 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 otc - active ingredient, otc - purpose, warnings and precautions, how supplied, otc - ask doctor, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active Ingredients                  Purpose

Avobenzone 2%                     Sunscreens

Octinoxate 4%

ACTIVE INGREDIENTS/ACTIFS: Octinoxate 4.0%  Avobenzone 2.0%.

Otc - Purpose

Uses

  • Provides minimal protection against the adverse effects of the sun
  • Higher SPF gives more protection

Warnings And Precautions

Warnings

For external use only

When using this product keep out of eyes.  If contact occurs rinse thoroughly with cold water.  Avoid direct contact with fabric.

WARNINGS: Avoid getting directly in eyes.  If contact occurs rinse thoroughly with cold water.  Avoid direct contact with fabric.

MISE EN GARDE: Éviter tout contact avec les yeux.  En cas de projection, rincer immédiatement à l'eau froide.  Éviter tout contact direct avec du tissu.

How Supplied

Colour may vary due to natural extracts

Colour may vary due to natural extracts.La couleur peut varier en raison des extraits naturels.

Otc - Ask Doctor

Stop use and ask a doctor if rash or irritation develops and lasts.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.  If swallowed, get medical help.

Indications & Usage

Directions

  • Massage into hands daily
  • Apply evenly at least 15 minutes before sun exposure.
  • Reapply as required.
  • Not intended for children under the age of 12.
  • Not intended for protection while sunbathing.
  • DIRECTIONS: Massage into hands daily.

    MODE D'EMPLOI: Massage des main au quotidian.

Storage And Handling

Other Information

Do not store above 30oC or 86oF.

Inactive Ingredient

Inactive ingredients

Aqua (Water), C12-15 alkyl benzoate, Butylene glycol, Dimethicone, Cetyl alcohol, Paraffinum liquidum (Mineral oil), Sorbitan stearate, Petrolatum, C18-36 acid glycol ester, Glycerin, Butyrospermum parkii (Shea butter), Phenoxyethanol, Vaccinium myrtillus extract, Carbomer, Methylparaben, Xanthan gum, Parfum (Fragrance), Propylparaben, Potassium hydroxide, Sucrose cocoate, Equisetum arvense extract, Dipropylene glycol, Tetrasodium EDTA, BHT

Otc - Questions

USA: Questions? 1-866-75-BOOTS

Description

EXTRACTS AUTHENTICATED BY ROYAL BOTANIC GARDENS KEW

ACTIVE PLANT EXTRACTS

Plant extracts at levels that really work, combined and formulated for unbeatable product performance.

Naturally.

Hands show the signs of ageing just as much as the face.  This light cream helps protect hands from free radical damage and premature skin ageing.  Easily absorbed so you can use it all day long, it sinks into skin to plump and moisturise leaving your hands beautifully soft, smooth and supple.

Dermatologically tested.

Tube label

ACTIVE PLANT EXTRACTS

Plant extract at levels that really work.  Naturally. 

This light cream helps protect hands from free radical damage and premature skin ageing.  Easily absorbed so you can use it all day long.

Dermatologically tested.


EXTRAITS ACTIFS DE PLANTES

Des extraits de plantes à des degrés efficaces.  Tout naturellement.

Cette crème légère aide à protéger les main des radicaux libres et lutte contre le vieillissement prematuré.  Facilement absorbée, elle peau être utilisée tout au long de la journée.

Dermo-testé

Information For Patients

Mfd in the U.K. for BBI NG2 3AA. UK.

Dist in the USA by Boots Retail USA Inc. Stamford CT 06901

USA: Questions? 1-866-75-BOOTS

www.boots.com

EXTRACTS AUTHENTICATED BY ROYAL BOTANIC GARDENS KEW

EXTRAITS APPROUVES PAR LES JARDINS BOTANIQUES ROYAUX DE KEW

Mfd in the U.K. for/Fabriqué au R.-U. pour BBI NG2 3AA. UK.

Dist in the USA by/aux É.-U. par Boots Retail USA Inc. Stamford CT 06901

USA/Canada: Questions? 1-866-75-BOOTS

www.boots.com

Package Label.Principal Display Panel

Carton label

Daily Hand Therapy Sunscreen SPF 10

Bilberry to protect and brighten

Cure Quotidienne Des Main Protection Solaire FPS 10

La myrtille protège et éclaircit

Boots

The Power of Plants

Botanics

75ml e 2.5 US Fl. Oz

Daily Hand Therapy carton.jpg

Tube label

Daily Hand Therapy Sunscreen SPF 10

Bilberry to protect and brighten

Cure Quotidienne Des Main Protection Solaire FPS 10

La myrtille protège et éclaircit

Boots

The Power of Plants

Botanics

75ml e 2.5 US Fl. Oz

Daily Hand Therapy label.jpg

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