SPL v1
SPL
SPL Set ID a1510c75-417e-46d6-bb7d-c9004760f614
Route
TOPICAL
Published
Effective Date 2018-07-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Mineral Oil (7.26 g) Octinoxate (0.40 g)
Inactive Ingredients
Butylene Glycol 1,2-hexanediol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2018-07-01

Description

Active ingredients: Mineral Oil 72.66%, Ethylhexyl Methoxycinnamate 4%

Purpose

Purpose: Skin Protectant, Sun protection


Medication Information

Purpose

Purpose: Skin Protectant, Sun protection

Description

Active ingredients: Mineral Oil 72.66%, Ethylhexyl Methoxycinnamate 4%

Uses

Uses:

Volume essence for moisturized and plump lips.

Warnings

Warnings:

1) In case of swelling, redness, itching or any severe allergic reactions while using the product, 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 from direct sunlight.

Directions

Directions:

Apply on dry lips as often as needed.

Active Ingredient

Active ingredients: Mineral Oil 72.66%, Ethylhexyl Methoxycinnamate 4%

Inactive Ingredient

Inactive ingredients:

Polymethyl Methacrylate,Synt hetic Beeswax,Hydrogenated Styrene/Isoprene Copol ymer,Caprylic/Capric Triglyceride,Oenothera Biennis (Evening Primrose) Oil, Camellia Japonica Seed Oil, Limnanthes Alba (Meadow foam) Seed Oil,Olea Europ aea (Olive) Fruit Oil,Vitis Vinifera (Grape) Seed Oil,W ater,Camellia Sinensis Leaf Oil,Moringa Oleifera Seed Oil,Oryza Sativa (Rice) Bran Oil,Sesamum Indicum (Sesa me) Seed Oil,Cocos Nucife ra (Coconut) Oil,Glycine So ja (Soybean) Oil,Perilla Ocy moides Seed Oil,Vegetable Oil,Butylene Glycol,1,2-Hexanediol,Tocopherol,Phosp hatidylcholine,Hydrolyzed Collagen,Ceramide NP,Gly cine,Glutamic Acid,Serine,L ysine,Alanine,Arginine,Thre onine,Proline,Fragrance

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN

Package Label.principal Display Panel


Structured Label Content

Uses

Uses:

Volume essence for moisturized and plump lips.

Purpose (PURPOSE)

Purpose: Skin Protectant, Sun protection

Warnings (WARNINGS)

Warnings:

1) In case of swelling, redness, itching or any severe allergic reactions while using the product, 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 from direct sunlight.

Directions

Directions:

Apply on dry lips as often as needed.

Active Ingredient (ACTIVE INGREDIENT)

Active ingredients: Mineral Oil 72.66%, Ethylhexyl Methoxycinnamate 4%

Inactive Ingredient (INACTIVE INGREDIENT)

Inactive ingredients:

Polymethyl Methacrylate,Synt hetic Beeswax,Hydrogenated Styrene/Isoprene Copol ymer,Caprylic/Capric Triglyceride,Oenothera Biennis (Evening Primrose) Oil, Camellia Japonica Seed Oil, Limnanthes Alba (Meadow foam) Seed Oil,Olea Europ aea (Olive) Fruit Oil,Vitis Vinifera (Grape) Seed Oil,W ater,Camellia Sinensis Leaf Oil,Moringa Oleifera Seed Oil,Oryza Sativa (Rice) Bran Oil,Sesamum Indicum (Sesa me) Seed Oil,Cocos Nucife ra (Coconut) Oil,Glycine So ja (Soybean) Oil,Perilla Ocy moides Seed Oil,Vegetable Oil,Butylene Glycol,1,2-Hexanediol,Tocopherol,Phosp hatidylcholine,Hydrolyzed Collagen,Ceramide NP,Gly cine,Glutamic Acid,Serine,L ysine,Alanine,Arginine,Thre onine,Proline,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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