Birdie Glow Sparkle Lotion Spf 15

Birdie Glow Sparkle Lotion Spf 15
SPL v3
SPL
SPL Set ID 232abd5f-3568-9c97-e063-6394a90afd92
Route
TOPICAL
Published
Effective Date 2024-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Ethylhexyl Salicylate (5 g) Octocrylene (0.5 mL) Homosalate (0.72446 mL) Butyl Methoxydibenzoylmethane (1.0904 mL)
Inactive Ingredients
Jojoba Oil Fragrance 13576 Titanium Dioxide Caprylic/capric Triglyceride Mica Cyclohexasiloxane Shea Butter Ci 16035 Benzyl Benzoate Limonene, (+)- Linalool, (+/-)- Eugenol Coumarin Citral Microcrystalline Wax Geraniol Styrene/isoprene Copolymer (28:72; 210000 Mw) .beta.-citronellol, (r)- Benzyl Cinnamate Mineral Oil Cyclopentasiloxane Magnesium Potassium Aluminosilicate Fluoride Almond Oil Coconut Oil .alpha.-tocopherol Acetate Tin Oxide Ci 77491 Hydroxycitronellal

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-28

Description

Drug Facts Active Ingredients Purpose Octocrylene 7% ................................................... Sunscreen Ethylhexyl Salicylate 5% ..................................... Sunscreen Homosalate 5% ................................................... Sunscreen Butyl Methoxydibenzoylmethane 1% .................. Sunscreen


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.

· Adds a shimmery glow for on and off the golf course.

Dosage and Administration

How to Apply

Apply generously to the body for a luminous shimmer and protective layer that makes your skin glow. The natural ingredients provide additional sun protection.

This SPF 15 lotion offers sun protection with a natural shimmer and tint.

Embrace the sun safely with our blend of nourishing oils.

Description

Drug Facts Active Ingredients Purpose Octocrylene 7% ................................................... Sunscreen Ethylhexyl Salicylate 5% ..................................... Sunscreen Homosalate 5% ................................................... Sunscreen Butyl Methoxydibenzoylmethane 1% .................. Sunscreen

Section 50565-1

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

Section 51727-6

Mineral Oil, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Hydrogenated Styrene/Isoprene Copolymer, Microcrystalline Wax, Mica, Synthetic Fluorphlogopite, Cyclohexasiloxane, Titanium Dioxide, Tocopheryl Acetate, Tin Oxide, Fragrance, CI 77491, CI 16035, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Benzyl Benzoate, Limonene, Coumarin, Linalool, Citronellol, Hydroxycitronellal, Geraniol, Benzyl Cinnamate, Eugenol, Citral

Section 51945-4

Section 55105-1

Drug Facts

Active Ingredients Purpose

Octocrylene 7% ................................................... Sunscreen

Ethylhexyl Salicylate 5% ..................................... Sunscreen

Homosalate 5% ................................................... Sunscreen

Butyl Methoxydibenzoylmethane 1% .................. Sunscreen

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.

· Adds a shimmery glow for on and off the golf course.

Dosage and Administration (34068-7)

How to Apply

Apply generously to the body for a luminous shimmer and protective layer that makes your skin glow. The natural ingredients provide additional sun protection.

This SPF 15 lotion offers sun protection with a natural shimmer and tint.

Embrace the sun safely with our blend of nourishing oils.

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.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Mineral Oil, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Hydrogenated Styrene/Isoprene Copolymer, Microcrystalline Wax, Mica, Synthetic Fluorphlogopite, Cyclohexasiloxane, Titanium Dioxide, Tocopheryl Acetate, Tin Oxide, Fragrance, CI 77491, CI 16035, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Benzyl Benzoate, Limonene, Coumarin, Linalool, Citronellol, Hydroxycitronellal, Geraniol, Benzyl Cinnamate, Eugenol, Citral

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Drug Facts

Active Ingredients Purpose

Octocrylene 7% ................................................... Sunscreen

Ethylhexyl Salicylate 5% ..................................... Sunscreen

Homosalate 5% ................................................... Sunscreen

Butyl Methoxydibenzoylmethane 1% .................. Sunscreen

Section 60561-8 (60561-8)

Other information

· Protect this product from excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

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