46440bac-de69-e59c-e063-6394a90a76c0

SPL v1
SPL
SPL Set ID 46440bac-de69-e59c-e063-6394a90a76c0
Route
topical
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octisalate (3 g) homosalate (7 g) zinc oxide
Inactive Ingredients
sesamum indicum (sesame) seed oil green tea leaf ylang-ylang oil blackberry borago officinalis seed oil sodium chloride phenoxyethanol orange oil, cold pressed polyglyceryl-4 diisostearate/polyhydroxystearate/sebacate eugenia caryophyllus (clove) leaf oil tocopherol isononyl isononanoate laminaria japonica ethylhexylglycerin dimethicone hyaluronate sodium cetyl peg/ppg-10/1 dimethicone (hlb 2) synthetic beeswax 1,2-hexanediol aronia melanocarpa fruit juice sesamum indicum (sesame) seed undaria pinnatifida lentinula edodes mycelium magnesium aluminum silicate pinene sorbitan sesquioleate stearalkonium hectorite phenyl trimethicone chia seed pelargonium graveolens flower oil ferrous oxide dimethicone/vinyl dimethicone crosspolymer (hard particle) urtica dioica leaf titanium dioxide water linalyl acetate rice germ nigella sativa seed caprylyl glycol lavender oil linalool limonene, (+)- butylene glycol caprylic/capric triglyceride arbutin geraniol acetyl hexapeptide-8 synthetic wax (1200 mw) hydrogenated polyisobutene (450 mw) bergamot oil beta-caryophyllene adenosine pentylene glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-07-01

Purpose

Sunscreen

Description

Drug Facts


Medication Information

Warnings

For external use only

Purpose

Sunscreen

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor
  • 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
Other Information
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients

Water, Isononyl Isononanoate, Hydrogenated Polyisobutene, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Caprylic/Capric Triglyceride, Arbutin, Synthetic Beeswax, Phenyl Trimethicone, Sorbitan Sesquioleate, Dimethicone, Sodium Chloride, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Stearalkonium Hectorite, Magnesium Aluminum Silicate, Caprylyl Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Synthetic Wax, Pentylene Glycol, Borago Officinalis Seed Oil, Ethylhexylglycerin, Adenosine, Olea Europaea (Olive) Fruit Oil, Sesamum Indicum (Sesame) Seed Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Aronia Melanocarpa Fruit Extract, Camellia Sinensis Leaf Extract, Nigella Sativa Seed Extract, Laminaria Japonica Extract, Sesamum Indicum (Sesame) Seed Extract, Oryza Sativa (Rice) Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Undaria Pinnatifida Extract, Lavandula Angustifolia (Lavender) Oil, Cananga Odorata Flower Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Cymbopogon Martini Oil, Pelargonium Graveolens Flower Oil, Salvia Hispanica Seed Extract, Lentinus Edodes Extract, Michelia Alba Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Eucalyptus Globulus Leaf Oil, Urtica Dioica (Nettle) Extract, 1,2-Hexanediol, Michelia Alba Flower Oil, Tocopherol, Phenoxyethanol, Sodium Hyaluronate, Jasminum Grandiflorum (Jasmine) Flower Extract, Acetyl Hexapeptide-8, Titanium Dioxide, Iron Oxides

Description

Drug Facts

Use
  • helps prevent sunburn
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • rash occurs
Section 50567-7

When using this product

  • keep out of eyes. Rinse with water to remove.
Section 50570-1

Do not use

  • on damaged or broken skin
Active Ingredients

Octisalate 3%

Homosalate 7%

Zinc Oxide 7%

Questions Or Comments?

Visit us at www.yensa.com

Principal Display Panel 30 Ml Tube Label Deep Warm

YENSA

SKIN ON SKIN BC FOUNDATION

BB + CC, FULL COVERAGE BROAD SPECTRUM SPF 40 SUNSCREEN

8 SUPERBLACKS ESSENCE

Net 1 fl. oz. / 30 mL

Principal Display Panel 30 Ml Tube Label Tan Golden

YENSA

SKIN ON SKIN BC FOUNDATION

BB + CC, FULL COVERAGE BROAD SPECTRUM SPF 40 SUNSCREEN

8 SUPERBLACKS ESSENCE

Net 1 fl. oz. / 30 mL

Principal Display Panel 30 Ml Tube Label Deep Golden

YENSA

SKIN ON SKIN BC FOUNDATION

BB + CC, FULL COVERAGE BROAD SPECTRUM SPF 40 SUNSCREEN

8 SUPERBLACKS ESSENCE

Net 1 fl. oz. / 30 mL


Structured Label Content

Warnings

For external use only

Purpose

Sunscreen

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • children under 6 months of age: Ask a doctor
  • 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
Other Information (Other information)
  • protect the product in this container from excessive heat and direct sun
Inactive Ingredients (Inactive ingredients)

Water, Isononyl Isononanoate, Hydrogenated Polyisobutene, Butylene Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Caprylic/Capric Triglyceride, Arbutin, Synthetic Beeswax, Phenyl Trimethicone, Sorbitan Sesquioleate, Dimethicone, Sodium Chloride, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Stearalkonium Hectorite, Magnesium Aluminum Silicate, Caprylyl Glycol, Dimethicone/Vinyl Dimethicone Crosspolymer, Synthetic Wax, Pentylene Glycol, Borago Officinalis Seed Oil, Ethylhexylglycerin, Adenosine, Olea Europaea (Olive) Fruit Oil, Sesamum Indicum (Sesame) Seed Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Aronia Melanocarpa Fruit Extract, Camellia Sinensis Leaf Extract, Nigella Sativa Seed Extract, Laminaria Japonica Extract, Sesamum Indicum (Sesame) Seed Extract, Oryza Sativa (Rice) Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Undaria Pinnatifida Extract, Lavandula Angustifolia (Lavender) Oil, Cananga Odorata Flower Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Cymbopogon Martini Oil, Pelargonium Graveolens Flower Oil, Salvia Hispanica Seed Extract, Lentinus Edodes Extract, Michelia Alba Leaf Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Eucalyptus Globulus Leaf Oil, Urtica Dioica (Nettle) Extract, 1,2-Hexanediol, Michelia Alba Flower Oil, Tocopherol, Phenoxyethanol, Sodium Hyaluronate, Jasminum Grandiflorum (Jasmine) Flower Extract, Acetyl Hexapeptide-8, Titanium Dioxide, Iron Oxides

Use
  • helps prevent sunburn
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • rash occurs
Section 50567-7 (50567-7)

When using this product

  • keep out of eyes. Rinse with water to remove.
Section 50570-1 (50570-1)

Do not use

  • on damaged or broken skin
Active Ingredients (Active ingredients)

Octisalate 3%

Homosalate 7%

Zinc Oxide 7%

Questions Or Comments? (Questions or comments?)

Visit us at www.yensa.com

Principal Display Panel 30 Ml Tube Label Deep Warm (PRINCIPAL DISPLAY PANEL - 30 ML TUBE LABEL - DEEP WARM)

YENSA

SKIN ON SKIN BC FOUNDATION

BB + CC, FULL COVERAGE BROAD SPECTRUM SPF 40 SUNSCREEN

8 SUPERBLACKS ESSENCE

Net 1 fl. oz. / 30 mL

Principal Display Panel 30 Ml Tube Label Tan Golden (PRINCIPAL DISPLAY PANEL - 30 ML TUBE LABEL - TAN GOLDEN)

YENSA

SKIN ON SKIN BC FOUNDATION

BB + CC, FULL COVERAGE BROAD SPECTRUM SPF 40 SUNSCREEN

8 SUPERBLACKS ESSENCE

Net 1 fl. oz. / 30 mL

Principal Display Panel 30 Ml Tube Label Deep Golden (PRINCIPAL DISPLAY PANEL - 30 ML TUBE LABEL - DEEP GOLDEN)

YENSA

SKIN ON SKIN BC FOUNDATION

BB + CC, FULL COVERAGE BROAD SPECTRUM SPF 40 SUNSCREEN

8 SUPERBLACKS ESSENCE

Net 1 fl. oz. / 30 mL


Advanced Ingredient Data


Raw Label Data

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