49404-149 Dr.jart+ Premium Beauty Balm Light Medium-medium

49404-149 Dr.jart+ Premium Beauty Balm Light Medium-medium
SPL v4
SPL
SPL Set ID 45b1c2c6-a45b-4a45-bec9-e5341079c0a1
Route
TOPICAL
Published
Effective Date 2022-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (4.8 g) Zinc Cation (5 g) Octinoxate (6.8 g) Octisalate (4.5 g)
Inactive Ingredients
Water Cyclomethicone 6 Cyclomethicone 5 Glycerin Peg-10 Dimethicone (600 Cst) Talc Alkyl (c12-15) Benzoate Diphenylsiloxy Phenyl Trimethicone Niacinamide Dipropylene Glycol Disteardimonium Hectorite Magnesium Sulfate, Unspecified Form Dimethicone/vinyl Dimethicone Crosspolymer (hard Particle) Dimethicone Ferric Oxide Yellow Triethoxycaprylylsilane Phenoxyethanol Ferric Oxide Red Methicone (20 Cst) Ferrosoferric Oxide Polyglyceryl-6 Polyricinoleate Trihydroxystearin Ethylhexylglycerin Adenosine Orange Oil, Cold Pressed Lime Oil, Cold Pressed Pine Needle Oil (pinus Sylvestris) Butylated Hydroxytoluene Eucalyptus Oil Bergamot Oil Lemon Oil, Cold Pressed Tocopherol Allantoin 1,2-hexanediol Palmitoyl Tripeptide-5 Polysorbate 80 Platinum Palmitoyl Hexapeptide-12

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-25

Description

OCTINOXATE 6.8% OCTISALATE 4.5% TITANIUM DIOXIDE 4.8% ZINC OXIDE 5.0%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Helps prevent sunburn

Dosage and Administration

For sunscreen use:

■ apply liberally 15 minutes before sun exposure

■ reapply at least every two 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

■ children under 6 months of age: ask a doctor

Description

OCTINOXATE 6.8% OCTISALATE 4.5% TITANIUM DIOXIDE 4.8% ZINC OXIDE 5.0%

Section 44425-7

Protect the product in this container from excessive heat and direct sunlight

Section 50565-1

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 50566-9

Stop using 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

Section 51727-6

WATER, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, GLYCERIN, TITANIUM DIOXIDE(CI 77891), PEG-10 DIMETHICONE, TALC, C12-15 ALKYL BENZOATE, HEXYL LAURATE, DIPHENYLSILOXY PHENYL TRIMETHICONE, NIACINAMIDE, DIPROPYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, IRON OXIDES(CI 77491), METHICONE, IRON OXIDES(CI 77499), POLYGLYCERYL-6 POLYRICINOLEATE, TRIHYDROXYSTEARIN, ETHYLHEXYLGLYCERIN, ADENOSINE, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, CITRUS AURANTIFOLIA (LIME) OIL, PINUS SYLVESTRIS LEAF OIL, BHT, EUCALYPTUS GLOBULUS LEAF OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, CITRUS LIMON (LEMON) PEEL OIL, TOCOPHEROL, ALLANTOIN, 1,2-HEXANEDIOL, PALMITOYL TRIPEPTIDE-5, POLYSORBATE 80, PLATINUM POWDER, PALMITOYL HEXAPEPTIDE-12

Section 51945-4

Dr. Jart +

BB Premium Beauty Balm

Broad Spectrum SPF40

40 ml / 1.35 fl. oz.

Section 55105-1

Sunscreen

Section 55106-9

OCTINOXATE 6.8%

OCTISALATE 4.5%

TITANIUM DIOXIDE 4.8%

ZINC OXIDE 5.0%




Structured Label Content

Indications and Usage (34067-9)

Helps prevent sunburn

Dosage and Administration (34068-7)

For sunscreen use:

■ apply liberally 15 minutes before sun exposure

■ reapply at least every two 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

■ children under 6 months of age: ask a doctor

Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

Protect the product in this container from excessive heat and direct sunlight

Section 50565-1 (50565-1)

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Section 50566-9 (50566-9)

Stop using 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

Section 51727-6 (51727-6)

WATER, CYCLOPENTASILOXANE, CYCLOHEXASILOXANE, GLYCERIN, TITANIUM DIOXIDE(CI 77891), PEG-10 DIMETHICONE, TALC, C12-15 ALKYL BENZOATE, HEXYL LAURATE, DIPHENYLSILOXY PHENYL TRIMETHICONE, NIACINAMIDE, DIPROPYLENE GLYCOL, DISTEARDIMONIUM HECTORITE, MAGNESIUM SULFATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE, IRON OXIDES(CI 77492), TRIETHOXYCAPRYLYLSILANE, PHENOXYETHANOL, IRON OXIDES(CI 77491), METHICONE, IRON OXIDES(CI 77499), POLYGLYCERYL-6 POLYRICINOLEATE, TRIHYDROXYSTEARIN, ETHYLHEXYLGLYCERIN, ADENOSINE, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL, CITRUS AURANTIFOLIA (LIME) OIL, PINUS SYLVESTRIS LEAF OIL, BHT, EUCALYPTUS GLOBULUS LEAF OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL, CITRUS LIMON (LEMON) PEEL OIL, TOCOPHEROL, ALLANTOIN, 1,2-HEXANEDIOL, PALMITOYL TRIPEPTIDE-5, POLYSORBATE 80, PLATINUM POWDER, PALMITOYL HEXAPEPTIDE-12

Section 51945-4 (51945-4)

Dr. Jart +

BB Premium Beauty Balm

Broad Spectrum SPF40

40 ml / 1.35 fl. oz.

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

OCTINOXATE 6.8%

OCTISALATE 4.5%

TITANIUM DIOXIDE 4.8%

ZINC OXIDE 5.0%




Advanced Ingredient Data


Raw Label Data

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