SPL v1
SPL
SPL Set ID aa20424f-f2b3-4b1a-8e8d-cf8b48eebc2f
Route
TOPICAL
Published
Effective Date 2018-07-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.01 g) Octinoxate (2.50 g) Zinc Cation (1.50 g)
Inactive Ingredients
Glycerin Phenyl Trimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-07-01

Description

Active ingredients: Titanium Dioxide 8.02%, Ethylhexyl Methoxycinnamate 5.00%, Zinc Oxide 3.00%

Purpose

Purpose: Sunscreen


Medication Information

Purpose

Purpose: Sunscreen

Description

Uses:

This high performance, multi-functio nal BB cream is concentrated with 45% snail extract to help improve the con dition of damaged skin. Snail extract’s anti-inflammatory and healing properties promote the reduction of blemishes and encourage skin renewal.

Directions:

Take moderate amount and apply evenly over entire face at the last step in skin care

Warnings

[PRECAUTIONS]

1)In case of swell ing, redness, itching or any severe al lergic reactions while using the prod uct, discontinue use and consult with a specialist. 2) Do not apply on broken skin or wounded areas. 3) Precautions for storage and handling A) Keep out of reach of children. B) Store away f rom direct sunlight.

Active Ingredient

Active ingredients: Titanium Dioxide 8.02%, Ethylhexyl Methoxycinnamate 5.00%, Zinc Oxide 3.00%

Inactive Ingredient

Inactive ingredients:

Snail Secretion Filtrate,Cyclopen tasiloxane,Glycerin,Cyclohexasiloxane,CetylEthylhexanoate,PE G-10 Dimethicone,Phenyl Trime thicone,Niacinamide,Butylene Glycol Dicaprylate/Dicaprate,So dium Chloride,Ozokerite,Meth yl Methacrylate Crosspolymer, Disteardimonium Hectorite,Ce tyl PEG/PPG-10/1Dimethicone, Water,Tocopheryl Acetate,Allan toin,Panthenol,Boron Nitride,Ac rylates/Ammonium Methacrylate Copolymer,C12-15 Alkyl Benzoa te,Alcohol,Castanea Sativa (Ches tnut) Seed Extract,Propylene Gly col,Butylene Glycol,1,2-Hexaned iol,Lecithin,Caprylic/Capric Trigly ceride,Gentiana Lutea Root Extr act,Achillea Millefolium Extract,A rtemisia Absinthium Extract,Arni ca Montana Flower Extract,Diiso propyl Adipate,Lavandula Angusti folia (Lavender) Extract,Rosmarin us Officinalis (Rosemary) Leaf Ex tract,Thymus Vulgaris (Thyme) E xtract,Origanum Vulgare Leaf Ext ract,Ubiquinone,Carica Papaya (P apaya) Fruit Water,Sodium Hyalu ronate,Beta-Glucan,Vaccinium Ma crocarpon (Cranberry) Fruit Ex tract,Rubus Idaeus (Raspberry) Fruit Extract,Prunus Serotina (W ild Cherry) Fruit Extract,Cornus Officinalis Fruit Extract,Punica Gr anatum Fruit Extract,Potassium Sorbate,Triethyl Citrate,Caprylyl Methicone,Iron Oxides (CI 77492), Phenoxyethanol,Sorbitan Sesquio leate,Triethoxycaprylylsilane,Iron Oxides (CI 77491),Aluminum Hy droxide,Iron Oxides (CI 77499), Ethylhexylglycerin,Isotridecyl Ison onanoate,Adenosine,Disodium ED TA,Fragrance

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Purpose (PURPOSE)

Purpose: Sunscreen

Warnings (WARNINGS)

[PRECAUTIONS]

1)In case of swell ing, redness, itching or any severe al lergic reactions while using the prod uct, discontinue use and consult with a specialist. 2) Do not apply on broken skin or wounded areas. 3) Precautions for storage and handling A) Keep out of reach of children. B) Store away f rom direct sunlight.

Description (DESCRIPTION)

Uses:

This high performance, multi-functio nal BB cream is concentrated with 45% snail extract to help improve the con dition of damaged skin. Snail extract’s anti-inflammatory and healing properties promote the reduction of blemishes and encourage skin renewal.

Directions:

Take moderate amount and apply evenly over entire face at the last step in skin care

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Titanium Dioxide 8.02%, Ethylhexyl Methoxycinnamate 5.00%, Zinc Oxide 3.00%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Snail Secretion Filtrate,Cyclopen tasiloxane,Glycerin,Cyclohexasiloxane,CetylEthylhexanoate,PE G-10 Dimethicone,Phenyl Trime thicone,Niacinamide,Butylene Glycol Dicaprylate/Dicaprate,So dium Chloride,Ozokerite,Meth yl Methacrylate Crosspolymer, Disteardimonium Hectorite,Ce tyl PEG/PPG-10/1Dimethicone, Water,Tocopheryl Acetate,Allan toin,Panthenol,Boron Nitride,Ac rylates/Ammonium Methacrylate Copolymer,C12-15 Alkyl Benzoa te,Alcohol,Castanea Sativa (Ches tnut) Seed Extract,Propylene Gly col,Butylene Glycol,1,2-Hexaned iol,Lecithin,Caprylic/Capric Trigly ceride,Gentiana Lutea Root Extr act,Achillea Millefolium Extract,A rtemisia Absinthium Extract,Arni ca Montana Flower Extract,Diiso propyl Adipate,Lavandula Angusti folia (Lavender) Extract,Rosmarin us Officinalis (Rosemary) Leaf Ex tract,Thymus Vulgaris (Thyme) E xtract,Origanum Vulgare Leaf Ext ract,Ubiquinone,Carica Papaya (P apaya) Fruit Water,Sodium Hyalu ronate,Beta-Glucan,Vaccinium Ma crocarpon (Cranberry) Fruit Ex tract,Rubus Idaeus (Raspberry) Fruit Extract,Prunus Serotina (W ild Cherry) Fruit Extract,Cornus Officinalis Fruit Extract,Punica Gr anatum Fruit Extract,Potassium Sorbate,Triethyl Citrate,Caprylyl Methicone,Iron Oxides (CI 77492), Phenoxyethanol,Sorbitan Sesquio leate,Triethoxycaprylylsilane,Iron Oxides (CI 77491),Aluminum Hy droxide,Iron Oxides (CI 77499), Ethylhexylglycerin,Isotridecyl Ison onanoate,Adenosine,Disodium ED TA,Fragrance

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

KEEP OUT OF REACH OF CHILDREN

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


Advanced Ingredient Data


Raw Label Data

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