Everyday Spf 30 With Sunflower Extract

Everyday Spf 30 With Sunflower Extract
SPL v6
SPL
SPL Set ID 81b9fda2-bd55-1b90-e053-2991aa0a765a
Route
TOPICAL
Published
Effective Date 2019-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (3 g) Homosalate (10 g) Octisalate (5 g)
Inactive Ingredients
Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Eucalyptus Globulus Leaf Citric Acid Monohydrate Diethylhexyl Syringylidenemalonate Rosewood Oil Chlorphenesin Orange Oil Lemon Oil Glycerin Isodecyl Neopentanoate Ethylhexylglycerin 1,2-hexanediol Caprylyl Glycol Xanthan Gum Allantoin Panthenol Sodium Tripolyphosphate Anhydrous Water Butyl Acrylate/methyl Methacrylate/methacrylic Acid Copolymer (18000 Mw) Diisopropyl Sebacate Isododecane Lauryl Lactate Cetyl Alcohol Potassium Cetyl Phosphate Rice Bran Cetearyl Olivate Hydroxyacetophenone Sorbitan Olivate Pelargonium Graveolens Flower Oil Pentylene Glycol Trisodium Ethylenediamine Disuccinate Behenic Acid Cetyl Behenate Isostearyl Stearate Tocopherol Medium-chain Triglycerides

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-12

Description

Active Ingredients Purpose Avobenzone 3% Sunscreen Homosalate 10% Sunscreen Octisalate 5% Sunscreen


Medication Information

Warnings and Precautions

Warnings

For external use only

Do not use on damaged or broken skin.

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

Indications and Usage

Stop use and ask a doctor if rash occurs.

Dosage and Administration

Directions

  • Apply gerenously and evenly 15 minutes before sun exsposure
  • Reapply

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

  • 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
  • Children under 6 months: Ask a doctor
Description

Active Ingredients Purpose Avobenzone 3% Sunscreen Homosalate 10% Sunscreen Octisalate 5% Sunscreen

Section 50565-1

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

Section 51727-6

Inactive Ingredients

Water, Polyester-8, Acrylates Copolymer, Diisopropyl Sebacate, Glycerin, Isodecyl Neopentanoate, Isododecane, Lauryl Lactate, Cetyl Alcohol, Potassium Cetyl Phosphate, Brassica Campstris/Aleurites Fordi Oil Copolymer, Oryza Sativa (Rice) Bran Extract, Cetearyl Olivate, Ammonium Acryloyldimethyltaurate/ VP Copolymer, Hydroxyacetophenone, Sorbitan Olivate, Diethylhexyl Syringylidenemalonate, Aniba Roseodora (Rosewood) Wood Oil, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Ethyhexylglycerin, Eucaluptyus Globulus Leaf Oil, Ocimum Basilicum (Basil) Flower/Leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, Pentylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Xanthan Gum, Helianthus Annuus (sunflower) Extract, Behenic Acid, Cetyl Behenate, Isostearyl Isostearate, Trisodium Ethylenediamine Disuccinate, Tocopherol, Allantoin, Rosmarinus Officinialis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride, Panthenol, Pentasodium Triphosphate, Citric Acid

Section 51945-4

Everyday Sunscreen with Sunflower Extract

Broad Spectrum SPF 30

2.4 fl. oz. 71 ml

Everyday Sunscreen with Sunflower Extract

Broad Spectrum SPF 30

162 ml

Section 55105-1

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 casused by the sun
Section 55106-9

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen


Structured Label Content

Indications and Usage (34067-9)

Stop use and ask a doctor if rash occurs.

Dosage and Administration (34068-7)

Directions

  • Apply gerenously and evenly 15 minutes before sun exsposure
  • Reapply

after 80 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

  • 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
  • Children under 6 months: Ask a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only

Do not use on damaged or broken skin.

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Inactive Ingredients

Water, Polyester-8, Acrylates Copolymer, Diisopropyl Sebacate, Glycerin, Isodecyl Neopentanoate, Isododecane, Lauryl Lactate, Cetyl Alcohol, Potassium Cetyl Phosphate, Brassica Campstris/Aleurites Fordi Oil Copolymer, Oryza Sativa (Rice) Bran Extract, Cetearyl Olivate, Ammonium Acryloyldimethyltaurate/ VP Copolymer, Hydroxyacetophenone, Sorbitan Olivate, Diethylhexyl Syringylidenemalonate, Aniba Roseodora (Rosewood) Wood Oil, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Limon (Lemon) Peel Oil, Ethyhexylglycerin, Eucaluptyus Globulus Leaf Oil, Ocimum Basilicum (Basil) Flower/Leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, Pentylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Xanthan Gum, Helianthus Annuus (sunflower) Extract, Behenic Acid, Cetyl Behenate, Isostearyl Isostearate, Trisodium Ethylenediamine Disuccinate, Tocopherol, Allantoin, Rosmarinus Officinialis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride, Panthenol, Pentasodium Triphosphate, Citric Acid

Section 51945-4 (51945-4)

Everyday Sunscreen with Sunflower Extract

Broad Spectrum SPF 30

2.4 fl. oz. 71 ml

Everyday Sunscreen with Sunflower Extract

Broad Spectrum SPF 30

162 ml

Section 55105-1 (55105-1)

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 casused by the sun
Section 55106-9 (55106-9)

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen


Advanced Ingredient Data


Raw Label Data

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