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.
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.

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
  • 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

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

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

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.
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.

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

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

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

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