Birdie Glow Tinted Glow Moisturizer Spf 30

Birdie Glow Tinted Glow Moisturizer Spf 30
SPL v3
SPL
SPL Set ID 22745ac1-3322-7be9-e063-6294a90ae014
Route
TOPICAL
Published
Effective Date 2024-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (0.0225 mL) Octocrylene (0.1125 mL) Homosalate (0.06 mL) Ethylhexyl Salicylate (5 mL) Octinoxate (2 mL)
Inactive Ingredients
Trideceth-9 Light Mineral Oil Sorbitan Oleate Octyldodecyl Stearoyl Stearate Glycerin Cetearyl Alcohol Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Isononyl Isononanoate Tin Oxide Edetate Disodium Disteardimonium Hectorite Bht Propylene Carbonate Methacrylate/methoxy Peg-10 Maleate/styrene Copolymer Sodium Hyaluronate Ci 77499 Polyhydroxystearic Acid (2300 Mw) Triethoxycaprylylsilane 1,2-hexanediol Coconut Oil Aloe Vera Leaf Ci 77891 Water Shea Butter Mica .alpha.-tocopherol Acetate Magnesium Potassium Aluminosilicate Fluoride Hydroxyacetophenone Ci 77491 Ammonium Acryloyldimethyltaurate/vp Copolymer Polyglyceryl-3 Diisostearate Ci 77492 Sodium Polyacrylate (8000 Mw) Paraffinum Liquidum Polysorbate 60 Polyglyceryl-6 Behenate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-20

Description

Octocrylene 9% Homosalate 5% Ethylhexyl Salicylate 4.8% Ethylhexyl Methoxycinnamate 4.5954%. Butyl Methoxydibenzoylmethane 2.7%


Medication Information

Warnings and Precautions

Warnings

· For external use only.

· Do not use on damaged skin.

· Avoid contact with eyes. Rinse with water if needed.

· Stop use if rash occurs.

· Keep out of reach of children. In case of ingestion, get medical help.

Indications and Usage

Uses

Helps prevent sunburn, decreases the risk of skin cancer and early skin aging if used as directed.

SPF protection

Perfect for all skin types

Dosage and Administration

Apply liberally 15 minutes before

sun exposure; reapply at least

every 2 hours; use a water-resis-

tant sunscreen if swimming or

sweating; children under 6 months:

ask a doctor.

Description

Achieve a radiant, sun-kissed look with our Birdie Glow Fore Face Tinted Glow SPF Moisturizer. This lightweight formula provides a sheer tint while protecting your skin with SPF, making it perfect for your daily skincare routine.

Section 43683-2

Indications & Usage

Updated indication wording for clarity (no change in therapeutic intent).

Dosage and Administration

Updated direction wording for clarity (no change in therapeutic intent).

Section 50565-1

· Keep out of reach of children. In case of ingestion, get medical help.

Section 51727-6

Water, Glycerin, Macadamia Seed Oil Polyglyceryl-6 Esters Behenate, Cetearyl Alcohol, Polyglyceryl-3 Diisostearate, Polysorbate 60, CI 77891, Mica, Tocopheryl Acetate, Synthetic Fluorphlogopite, Hydroxyacetophenone, 1,2-Hexanediol, CI 77491, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ammonium Polyacrylate, Paraffinum Liquidum, Aloe Barbadensis Leaf Water, Cocos Nucifera (Coconut) Oil, CI 77492, Isononyl Isononanoate, Mineral Oil, Butyrospermum Parkii (Shea) Butter, Sodium Hyaluronate, Tin Oxide, CI 77499, Octyldodecyl Stearoyl Stearate, Disodium EDTA, Triethoxycaprylylsilane, Sorbitan Oleate, Trideceth-9, Polyhydroxystearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, BHT, Styrene/Butadiene Copolymer, Propylene Carbonate

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Octocrylene 9%

Homosalate 5%

Ethylhexyl Salicylate 4.8%

Ethylhexyl Methoxycinnamate 4.5954%.

Butyl Methoxydibenzoylmethane 2.7%

Section 60561-8

Other information

· Protect this product from excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

Uses

Helps prevent sunburn, decreases the risk of skin cancer and early skin aging if used as directed.

SPF protection

Perfect for all skin types

Dosage and Administration (34068-7)

Apply liberally 15 minutes before

sun exposure; reapply at least

every 2 hours; use a water-resis-

tant sunscreen if swimming or

sweating; children under 6 months:

ask a doctor.

Warnings and Precautions (34071-1)

Warnings

· For external use only.

· Do not use on damaged skin.

· Avoid contact with eyes. Rinse with water if needed.

· Stop use if rash occurs.

· Keep out of reach of children. In case of ingestion, get medical help.

Description (34089-3)

Achieve a radiant, sun-kissed look with our Birdie Glow Fore Face Tinted Glow SPF Moisturizer. This lightweight formula provides a sheer tint while protecting your skin with SPF, making it perfect for your daily skincare routine.

Section 43683-2 (43683-2)

Indications & Usage

Updated indication wording for clarity (no change in therapeutic intent).

Dosage and Administration

Updated direction wording for clarity (no change in therapeutic intent).

Section 50565-1 (50565-1)

· Keep out of reach of children. In case of ingestion, get medical help.

Section 51727-6 (51727-6)

Water, Glycerin, Macadamia Seed Oil Polyglyceryl-6 Esters Behenate, Cetearyl Alcohol, Polyglyceryl-3 Diisostearate, Polysorbate 60, CI 77891, Mica, Tocopheryl Acetate, Synthetic Fluorphlogopite, Hydroxyacetophenone, 1,2-Hexanediol, CI 77491, Ammonium Acryloyldimethyltaurate/VP Copolymer, Ammonium Polyacrylate, Paraffinum Liquidum, Aloe Barbadensis Leaf Water, Cocos Nucifera (Coconut) Oil, CI 77492, Isononyl Isononanoate, Mineral Oil, Butyrospermum Parkii (Shea) Butter, Sodium Hyaluronate, Tin Oxide, CI 77499, Octyldodecyl Stearoyl Stearate, Disodium EDTA, Triethoxycaprylylsilane, Sorbitan Oleate, Trideceth-9, Polyhydroxystearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, BHT, Styrene/Butadiene Copolymer, Propylene Carbonate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Octocrylene 9%

Homosalate 5%

Ethylhexyl Salicylate 4.8%

Ethylhexyl Methoxycinnamate 4.5954%.

Butyl Methoxydibenzoylmethane 2.7%

Section 60561-8 (60561-8)

Other information

· Protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)