43526-129_ipkn Moist And Firm Beauty Balm Light Medium

43526-129_ipkn Moist And Firm Beauty Balm Light Medium
SPL v1
SPL
SPL Set ID 1af6184e-3dc4-4eb3-8d51-aca724473451
Route
TOPICAL
Published
Effective Date 2024-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ci 77891 (65.1 mg)
Inactive Ingredients
Hexyl Laurate Isoeicosane Niacinamide Pentylene Glycol Mica Butylene Glycol Dicaprylate/dicaprate Disteardimonium Hectorite Panthenol Talc Magnesium Sulfate, Unspecified Form Ferric Oxide Red 2-ethylhexyl Acrylate, Methacrylate, Methyl Methacrylate, Or Butyl Methacrylate/hydroxypropyl Dimethicone Copolymer (30000-300000 Mw) Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Sorbitan Sesquioleate Ferrosoferric Oxide Polyglyceryl-4 Isostearate Aluminum Hydroxide Triethoxycaprylylsilane Stearic Acid Aluminum Oxide Glyceryl Behenate/eicosadioate Glyceryl Monocaprylate Isopropyl Titanium Triisostearate Hyaluronic Acid Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer Adenosine Trisodium Ethylenediamine Disuccinate Moringa Oleifera Seed Oil Ceramide Np Phytosphingosine Hydrogenated Soybean Lecithin Water Cyclomethicone 5 Glycerin Ferric Oxide Yellow Peg-10 Dimethicone (200 Cst) Phenyl Trimethicone Triethylhexanoin Isododecane Octyldodecanol Cetyl Ethylhexanoate Dipropylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-25

Description

Titanium Dioxide 6.51%


Medication Information

Warnings and Precautions

 For external use only

 Do not use on damaged or broken skin

 Stop using and ask a doctor if rash occurs

 When using this product, keep out of eyes. Rinse with water to remove

 Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

Indications and Usage

 Helps prevent sunburn

 If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun

Dosage and Administration

For sunscreen use:

 Apply liberally 15 minutes before sun exposure

 Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

 Ask a doctor to use for children under 6 months

Description

Titanium Dioxide 6.51%

Section 50565-1

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6

Water, Cyclopentasiloxane, Titanium Dioxide (CI 77891), Glycerin, Iron Oxides (CI 77492), PEG-10 Dimethicone, Phenyl Trimethicone, Triethylhexanoin, Isododecane, Octyldodecanol, Cetyl Ethylhexanoate, Dipropylene Glycol, Hexyl Laurate, Isoeicosane, Niacinamide, Pentylene Glycol, Mica (CI 77019), Butylene Glycol Dicaprylate/Dicaprate, Disteardimonium Hectorite, Panthenol, Talc, Magnesium Sulfate, Iron Oxides (CI 77491), Acrylates/Dimethicone Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Sorbitan Sesquioleate, Iron Oxides (CI 77499), Polyglyceryl-4 Isostearate, Aluminum Hydroxide, Triethoxycaprylylsilane, Stearic Acid, Alumina, Glyceryl Behenate/Eicosadioate, Glyceryl Caprylate, Isopropyl Titanium Triisostearate, Hydrolyzed Hyaluronic Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Adenosine, Trisodium Ethylenediamine Disuccinate, Moringa Oleifera Seed Oil, Ceramide NP, Phytosphingosine, Hydrogenated Lecithin

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Titanium Dioxide 6.51%


Structured Label Content

Indications and Usage (34067-9)

 Helps prevent sunburn

 If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun

Dosage and Administration (34068-7)

For sunscreen use:

 Apply liberally 15 minutes before sun exposure

 Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses

 Ask a doctor to use for children under 6 months

Warnings and Precautions (34071-1)

 For external use only

 Do not use on damaged or broken skin

 Stop using and ask a doctor if rash occurs

 When using this product, keep out of eyes. Rinse with water to remove

 Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

Section 50565-1 (50565-1)

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 51727-6 (51727-6)

Water, Cyclopentasiloxane, Titanium Dioxide (CI 77891), Glycerin, Iron Oxides (CI 77492), PEG-10 Dimethicone, Phenyl Trimethicone, Triethylhexanoin, Isododecane, Octyldodecanol, Cetyl Ethylhexanoate, Dipropylene Glycol, Hexyl Laurate, Isoeicosane, Niacinamide, Pentylene Glycol, Mica (CI 77019), Butylene Glycol Dicaprylate/Dicaprate, Disteardimonium Hectorite, Panthenol, Talc, Magnesium Sulfate, Iron Oxides (CI 77491), Acrylates/Dimethicone Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Sorbitan Sesquioleate, Iron Oxides (CI 77499), Polyglyceryl-4 Isostearate, Aluminum Hydroxide, Triethoxycaprylylsilane, Stearic Acid, Alumina, Glyceryl Behenate/Eicosadioate, Glyceryl Caprylate, Isopropyl Titanium Triisostearate, Hydrolyzed Hyaluronic Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Adenosine, Trisodium Ethylenediamine Disuccinate, Moringa Oleifera Seed Oil, Ceramide NP, Phytosphingosine, Hydrogenated Lecithin

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Titanium Dioxide 6.51%


Advanced Ingredient Data


Raw Label Data

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