Ceramide Lift And Firm Day Cream Broad Spectrum Sunscreen Spf 30

Ceramide Lift And Firm Day Cream Broad Spectrum Sunscreen Spf 30
SPL v3
SPL
SPL Set ID b20ae6e9-de6e-0059-e053-2a95a90a5760
Route
TOPICAL
Published
Effective Date 2020-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxybenzone (5 mg) Octisalate (7.5 mg) Octinoxate (2.2 mg) Octocrylene
Inactive Ingredients
Sucrose Acetyl Octapeptide-3 Cetostearyl Alcohol Alkyl (c12-15) Benzoate Isostearyl Neopentanoate Water Dimethicone .alpha.-tocopherol Acetate Trifolium Pratense Flower Ceramide 6 Ii Ceramide 3 Cyclomethicone 5 Butylene Glycol Vitamin A Palmitate Isomethyl-.alpha.-ionone Cocoa Butter Ppg-2 Isoceteth-20 Acetate Egg Phospholipids Butylphenyl Methylpropional Citral Ceramide 1 Polyethylene Glycol 400 Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Cholesterol Ascorbyl Palmitate Xanthan Gum Methylparaben Butyrospermum Parkii (shea) Butter Unsaponifiables Glycerin Hexylene Glycol Abelmoschus Moschatus Seed Hydrogenated Soybean Lecithin Leuconostoc/radish Root Ferment Filtrate Lecithin, Soybean Mineral Oil Phytosphingosine Limonene, (+)- Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Alpinia Zerumbet Leaf Caprylyl Glycol Carbomer Homopolymer, Unspecified Type Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Isohexadecane Urea Phenoxyethanol Retinyl Linoleate Hyaluronate Sodium Sodium Hydroxide Benzoic Acid Propylene Glycol Cyclomethicone 6 Butylated Hydroxytoluene Linalool, (+/-)- Fd&c Yellow No. 6 Sodium Lauroyl Lactylate Sodium Pyrrolidone Carboxylate Polyquaternium-51 (2-methacryloyloxyethyl Phosphorylcholine/n-butyl Methacrylate; 4:1) Polysorbate 60 Medium-chain Triglycerides Geraniol Phenyl Trimethicone Trehalose Fd&c Red No. 4 Chlorphenesin Trideceth-6

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-10-24

Description

OCTINOXATE 7.5%.................................. Sunscreen OXYBENZONE 5.0%................................ Sunscreen OCTISALATE 5.0% .................................. Sunscreen OCTOCRYLENE 2.2% ............................. Sunscreen AVOBENZONE 2.0%................................ Sunscreen


Medication Information

Warnings and Precautions

Warnings

  • For external use only
  • Do not use on damage or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs.
  • 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
Dosage and Administration

As needed

Description

OCTINOXATE 7.5%.................................. Sunscreen OXYBENZONE 5.0%................................ Sunscreen OCTISALATE 5.0% .................................. Sunscreen OCTOCRYLENE 2.2% ............................. Sunscreen AVOBENZONE 2.0%................................ 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

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 51945-4

Section 55105-1

Sunscreen

Warnings

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.

■ Stop use and ask a doctor if rash occurs

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

Other Ingredients

WATER/AQUA/EAU, DIMETHICONE, C12-15 ALKYL BENZOATE, BUTYLENE GLYCOL, ISOSTEARYL NEOPENTANOATE, CYCLOPENTASILOXANE, THEOBROMA CACAO (COCOA) SEED BUTTER, PPG-2 ISOCETETH-20 ACETATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCERIN, ACETYL OCTAPEPTIDE-3, ACRYLAMIDE/SODIUM ACRYLATE COPOLYMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALPINIA SPECIOSA LEAF EXTRACT, ASCORBYL PALMITATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL, CARBOMER, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, CETEARYL ALCOHOL, CETEARYL DIMETHICONE CROSSPOLYMER, CHOLESTEROL, CYCLOHEXASILOXANE, DIMETHICONE CROSSPOLYMER, DIMETHICONOL, HEXYLENE GLYCOL, HIBISCUS ABELMOSCHUS SEED EXTRACT, HYDROGENATED LECITHIN, HYDROGENATED PHOSPHATIDYLCHOLINE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, LECITHIN, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINERALE, PARFUM/FRAGRANCE, PEG-8, PHENYL TRIMETHICONE, PHOSPHOLIPIDS, PHYTOSPHINGOSINE, POLYPHOSPHORYLCHOLINE GLYCOL ACRYLATE, POLYQUATERNIUM-51, POLYSORBATE 60, PROPYLENE GLYCOL, RETINYL LINOLEATE, RETINYL PALMITATE, SODIUM HYALURONATE, SODIUM HYDROXIDE, SODIUM LAUROYL LACTYLATE, SODIUM PCA, SUCROSE, TOCOPHERYL ACETATE, TREHALOSE, TRIDECETH-6, TRIFOLIUM PRATENSE (CLOVER) FLOWER EXTRACT, UREA, XANTHAN GUM, BHT, ALPHA-ISOMETHYL IONONE, BUTYLPHENYL METHYLPROPIONAL, CITRAL, GERANIOL, LIMONENE, LINALOOL, BENZOIC ACID, CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, RED 4 (CI 14700), YELLOW 6 (CI 15985).

Active Ingredients

OCTINOXATE 7.5%.................................. Sunscreen

OXYBENZONE 5.0%................................ Sunscreen

OCTISALATE 5.0% .................................. Sunscreen

OCTOCRYLENE 2.2% ............................. Sunscreen

AVOBENZONE 2.0%................................ Sunscreen

Directions for Sunscreen Use

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

■ 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 or

higher and other sun protection measures including:

■ Limit time in the sun, especially from 10 a.m. – 2 p.m.

■ Wear long-sleeve shirts, pants, hats, and sunglasses

■ Children under 6 months: Ask a doctor.


Structured Label Content

Uses (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

Indications and Usage (34067-9)
  • Helps prevent sunburn
Dosage and Administration (34068-7)

As needed

Warnings and Precautions (34071-1)

Warnings

  • For external use only
  • Do not use on damage or broken skin
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs.
  • 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 children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Warnings (WARNINGS)

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.

■ Stop use and ask a doctor if rash occurs

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

Other Ingredients (OTHER INGREDIENTS)

WATER/AQUA/EAU, DIMETHICONE, C12-15 ALKYL BENZOATE, BUTYLENE GLYCOL, ISOSTEARYL NEOPENTANOATE, CYCLOPENTASILOXANE, THEOBROMA CACAO (COCOA) SEED BUTTER, PPG-2 ISOCETETH-20 ACETATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCERIN, ACETYL OCTAPEPTIDE-3, ACRYLAMIDE/SODIUM ACRYLATE COPOLYMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALPINIA SPECIOSA LEAF EXTRACT, ASCORBYL PALMITATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL, CARBOMER, CERAMIDE 1, CERAMIDE 3, CERAMIDE 6 II, CETEARYL ALCOHOL, CETEARYL DIMETHICONE CROSSPOLYMER, CHOLESTEROL, CYCLOHEXASILOXANE, DIMETHICONE CROSSPOLYMER, DIMETHICONOL, HEXYLENE GLYCOL, HIBISCUS ABELMOSCHUS SEED EXTRACT, HYDROGENATED LECITHIN, HYDROGENATED PHOSPHATIDYLCHOLINE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, LECITHIN, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINERALE, PARFUM/FRAGRANCE, PEG-8, PHENYL TRIMETHICONE, PHOSPHOLIPIDS, PHYTOSPHINGOSINE, POLYPHOSPHORYLCHOLINE GLYCOL ACRYLATE, POLYQUATERNIUM-51, POLYSORBATE 60, PROPYLENE GLYCOL, RETINYL LINOLEATE, RETINYL PALMITATE, SODIUM HYALURONATE, SODIUM HYDROXIDE, SODIUM LAUROYL LACTYLATE, SODIUM PCA, SUCROSE, TOCOPHERYL ACETATE, TREHALOSE, TRIDECETH-6, TRIFOLIUM PRATENSE (CLOVER) FLOWER EXTRACT, UREA, XANTHAN GUM, BHT, ALPHA-ISOMETHYL IONONE, BUTYLPHENYL METHYLPROPIONAL, CITRAL, GERANIOL, LIMONENE, LINALOOL, BENZOIC ACID, CHLORPHENESIN, METHYLPARABEN, PHENOXYETHANOL, RED 4 (CI 14700), YELLOW 6 (CI 15985).

Active Ingredients (ACTIVE INGREDIENTS)

OCTINOXATE 7.5%.................................. Sunscreen

OXYBENZONE 5.0%................................ Sunscreen

OCTISALATE 5.0% .................................. Sunscreen

OCTOCRYLENE 2.2% ............................. Sunscreen

AVOBENZONE 2.0%................................ Sunscreen

Directions for Sunscreen Use (DIRECTIONS FOR SUNSCREEN USE)

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

■ 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 or

higher and other sun protection measures including:

■ Limit time in the sun, especially from 10 a.m. – 2 p.m.

■ Wear long-sleeve shirts, pants, hats, and sunglasses

■ Children under 6 months: Ask a doctor.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)