Dr.jart Premium Beauty Balm Light Medium-medium

Dr.jart Premium Beauty Balm Light Medium-medium
SPL v3
SPL
SPL Set ID 02a87c6b-3c7d-5942-e063-6294a90aa452
Route
TOPICAL
Published
Effective Date 2023-08-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (48 mg) Zinc Oxide (50 mg) Octinoxate (68 mg) Octisalate (45 mg)
Inactive Ingredients
Cyclomethicone 5 Cyclomethicone 6 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 Water Polysorbate 80 Platinum Palmitoyl Hexapeptide-12 Palmitoyl Tripeptide-5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-08-11 Until 2027-10-31

Description

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


Medication Information

Warnings and Precautions

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 using and ask a doctor if rash occurs.

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 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 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 55105-1

Sunscreen

Section 55106-9

OCTINOXATE 6.8%

OCTISALATE 4.5%

TITANIUM DIOXIDE 4.8%

ZINC OXIDE 5.0%



Section 60561-8

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

Principal Display Panel

BB Premium Beauty Balm

Multi-tasker with Niacinamide

Broad Spectrum SPF40

40 mL / 1.35 fl. oz.


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.

Do not use on damaged or broken skin.

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

Stop using and ask a doctor if rash occurs.

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 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 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

OCTINOXATE 6.8%

OCTISALATE 4.5%

TITANIUM DIOXIDE 4.8%

ZINC OXIDE 5.0%



Section 60561-8 (60561-8)

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

Principal Display Panel

BB Premium Beauty Balm

Multi-tasker with Niacinamide

Broad Spectrum SPF40

40 mL / 1.35 fl. oz.


Advanced Ingredient Data


Raw Label Data

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