49404-151 Dr.jart+ Premium Beauty Balm Deep Tan-deep

49404-151 Dr.jart+ Premium Beauty Balm Deep Tan-deep
SPL v2
SPL
SPL Set ID 3c346960-b76b-4241-a188-8ee694853078
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 5 Cyclomethicone 6 Glycerin Peg-10 Dimethicone (600 Cst) Talc Alkyl (c12-15) Benzoate Hexyl Laurate 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 Propylene Glycol Polysorbate 80 Platinum Palmitoyl Tripeptide-1

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.

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

Section 51945-4

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

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

Section 51945-4 (51945-4)

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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:11.015339 · Updated: 2026-03-14T23:03:06.131630