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Drug Facts
Sulwhasoo Perfecting Cushion No. 27
FDA Label NDC 43419-080
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amorepacific Corporation for the product Sulwhasoo Perfecting Cushion No. 27 (NDC 43419-080). 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 other, active ingredients w/w, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients W/W
OCTINOXATE 7%
TITANIUM DIOXIDE 4.15%
ZINC OXIDE 9.8%
Purpose
Sunscreen
Uses
- Helps prevent sunburn
- If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings
- For external use only
Otc - Do Not Use
- Do not use on broken skin.
Otc - When Using
- When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
- Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.
Directions
- Apply liberally 15 minutes before sun exposure
- Children under 6 months of age : Ask a doctor.
- Reapply at least every 2 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 value of 15 or higher and other sun protection measures including :
- Limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses.
Inactive Ingredients
Water / Aqua / Eau, Cyclopentasiloxane, Titanium Dioxide (CI 77891), Cyclohexasiloxane, Phenyl Trimethicone, PEG-10 Dimethicone, Butylene Glycol Dicaprylate/Dicaprate, Niacinamide, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Glycerin, Propanediol, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Polymethyl Methacrylate, Polyhydroxystearic Acid, Iron Oxides (CI 77492), Aluminum Hydroxide, Sodium Chloride, Trimethylsiloxysilicate, Stearic Acid, Triethoxycaprylylsilane, Fragrance / Parfum, Disteardimonium Hectorite, Butylene Glycol, Ethylhexyl Palmitate, Lecithin, Isostearic Acid, Isopropyl Palmitate, Polysorbate 80, Caprylyl Glycol, Iron Oxides (CI 77491), Hydrogenated Lecithin, Polyglyceryl-3 Polyricinoleate, Ethylhexylglycerin, Glyceryl Caprylate, Iron Oxides (CI 77499), Disodium EDTA, Adenosine, Honey / Mel / Miel, Acrylates/VP Copolymer, Nelumbo Nucifera Flower Extract, Polygonatum Officinale Rhizome/Root Extract, Rehmannia Glutinosa Root Extract, Paeonia Albiflora Root Extract, Lilium Candidum Bulb Extract, Beta-Glucan, Alcohol, Phenoxyethanol, Tocopherol, Sodium Hyaluronate
Other Information
- Protect the product in this container from excessive heat and direct sun.
- Sun alert : Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Principal Display Panel - 30 G Container Carton - No. 11 Porcelain(Pink)
Sulwhasoo
PERFECTING CUSHION
BROAD SPECTRUM 50+ SUNSCREEN
NO. 11
PORCELAIN(PINK)
30 g(15 g x 2) / Net wt. 1.05 oz.
No. 11 (11)
Principal Display Panel - 30 G Container Carton - No. 15 Ivory(Pink)
Sulwhasoo
PERFECTING CUSHION
BROAD SPECTRUM 50+ SUNSCREEN
NO. 15
IVORY(PINK)
30 g(15 g x 2) / Net wt. 1.05 oz.
No. 15 (15)
Principal Display Panel - 30 G Container Carton - No. 17 Ivory(Beige)
Sulwhasoo
PERFECTING CUSHION
BROAD SPECTRUM SPF50+ SUNSCREEN
NO. 17
IVORY(BEIGE)
30 g(15 g x 2) / Net wt. 1.05 oz.
No.17 (17)
Principal Display Panel - 30 G Container Carton - No. 21 Natural(Pink)
Sulwhasoo
PERFECTING CUSHION
BROAD SPECTRUM 50+ SUNSCREEN
NO. 21
NATURAL(PINK)
30 g(15 g x 2) / Net wt. 1.05 oz.
No. 21 (21)
Principal Display Panel - 30 G Container Carton - No. 23 Natural(Beige)
Sulwhasoo
PERFECTING CUSHION
BROAD SPECTRUM 50+ SUNSCREEN
NO. 23
NATURAL(BEIGE)
30 g(15 g x 2) / Net wt. 1.05 oz.
No. 23 (23)
Principal Display Panel - 30 G Container Carton - No. 25 Sand(Pink)
Sulwhasoo
PERFECTING CUSHION
BROAD SPECTRUM SPF50+ SUNSCREEN
NO. 25
SAND(PINK)
30 g(15 g x 2) / Net wt. 1.05 oz.
No. 25 (25)
Principal Display Panel - 30 G Container Carton - No. 27 Sand(Beige)
Sulwhasoo
PERFECTING CUSHION
BROAD SPECTRUM 50+ SUNSCREEN
NO. 27
SAND(BEIGE)
30 g(15 g x 2) / Net wt. 1.05 oz.
No. 27 (27)
Principal Display Panel - 30 G Container Carton - No. 31 Honey(Pink)
Sulwhasoo
PERFECTING CUSHION
BROAD SPECTRUM 50+ SUNSCREEN
NO. 31
HONEY(PINK)
30 g(15 g x 2) / Net wt. 1.05 oz.
No. 31 (31)
Principal Display Panel - 30 G Container Carton - No. 33 Honey(Beige)
Sulwhasoo
PERFECTING CUSHION
BROAD SPECTRUM 50+ SUNSCREEN
NO. 33
HONEY(BEIGE)
30 g(15 g x 2) / Net wt. 1.05 oz.
No. 33 (33)
Principal Display Panel - 30 G Container Carton - No. 37 Amber(Beige)
Sulwhasoo
PERFECTING CUSHION
BROAD SPECTRUM 50+ SUNSCREEN
NO. 37
AMBER(BEIGE)
30 g(15 g x 2) / Net wt. 1.05 oz.
No. 37 (37)
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