SPL v1
SPL
SPL Set ID 571076af-57fe-4f47-b819-1dadb7dbb32d
Route
TOPICAL
Published
Effective Date 2017-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (2.1 g) Homosalate (1.8 g) Octisalate (1.35 g)
Inactive Ingredients
Octyldodecyl Myristate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-01-03

Description

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Homosalate 6.0%, Ethylhexyl Salicylate 4.5%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Use: Helps prevent sunburn - if used as directed with other sun protection measures.

Directions: Use at the last step of basic skin care every morning. Take an adequate amount with the pipette, apply on skin, and gently pat to promote absorption into skin.

Warnings

Warnings: For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear. Do not use on - deep puncture wounds - animal bites - serious burns

Active Ingredient

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Homosalate 6.0%, Ethylhexyl Salicylate 4.5%

Inactive Ingredient

Inactive Ingredients: Caprylic/Capric Triglyceride, Octyldodecyl Myristate, Dimethicone, Phenyl Trimethicone, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Methyl Trimethicone, Glyceryl Caprylate, Fragrance, Caprylyl Glycol, Rosa Centifolia Flower Oil, Calendula Officinalis Flower Oil, Cocos Nucifera (Coconut) Oil, Rubus Idaeus (Raspberry) Seed Oil, Polyglyceryl-2 Triisostearate, Water, Methylpropanediol, Propanediol, Polyglyceryl-4 Caprate, Polyglyceryl-2 Dipolyhydroxystearate

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

Warnings: For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear. Do not use on - deep puncture wounds - animal bites - serious burns

Description (DESCRIPTION)

Use: Helps prevent sunburn - if used as directed with other sun protection measures.

Directions: Use at the last step of basic skin care every morning. Take an adequate amount with the pipette, apply on skin, and gently pat to promote absorption into skin.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Homosalate 6.0%, Ethylhexyl Salicylate 4.5%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive Ingredients: Caprylic/Capric Triglyceride, Octyldodecyl Myristate, Dimethicone, Phenyl Trimethicone, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Methyl Trimethicone, Glyceryl Caprylate, Fragrance, Caprylyl Glycol, Rosa Centifolia Flower Oil, Calendula Officinalis Flower Oil, Cocos Nucifera (Coconut) Oil, Rubus Idaeus (Raspberry) Seed Oil, Polyglyceryl-2 Triisostearate, Water, Methylpropanediol, Propanediol, Polyglyceryl-4 Caprate, Polyglyceryl-2 Dipolyhydroxystearate

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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