BIRDIE GLOW SPARKLELOTION SPF 15- birdie glow sparkle lotion spf 15 oil

Birdie Glow SparkleLotion SPF 15 by

Drug Labeling and Warnings

Birdie Glow SparkleLotion SPF 15 by is a Otc medication manufactured, distributed, or labeled by Foshan Miwei Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Drug Facts

Active Ingredients Purpose

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

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

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

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

INDICATIONS & 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.

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & 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.

INACTIVE INGREDIENT

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

OTHER SAFETY INFORMATION

Other information

· Protect this product from excessive heat and direct sun.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BIRDIE GLOW SPARKLELOTION SPF 15 
birdie glow sparkle lotion spf 15 oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84222-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
JOJOBA OIL (UNII: 724GKU717M)	2 mL  in 100 mL
FRAGRANCE 13576 (UNII: 5EM498GW35)	0.72446 mL  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	1.0904 mL  in 100 mL
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	5 mL  in 100 mL
MICA (UNII: V8A1AW0880)	2.8913 mL  in 100 mL
CYCLOMETHICONE 6 (UNII: XHK3U310BA)	2.68 mL  in 100 mL
CARROT SEED OIL (UNII: 595AO13F11)	2 mL  in 100 mL
SHEA BUTTER (UNII: K49155WL9Y)	1 mL  in 100 mL
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.5742 mL  in 100 mL
BENZYL BENZOATE (UNII: N863NB338G)	0.14156 mL  in 100 mL
LIMONENE, (+)- (UNII: GFD7C86Q1W)	0.04386 mL  in 100 mL
LINALOOL, (+/-)- (UNII: D81QY6I88E)	0.02287 mL  in 100 mL
COUMARIN (UNII: A4VZ22K1WT)	0.028 mL  in 100 mL
CITRAL (UNII: T7EU0O9VPP)	0.00183 mL  in 100 mL
CARNAUBA WAX (UNII: R12CBM0EIZ)	3 mL  in 100 mL
GERANIOL (UNII: L837108USY)	0.00518 mL  in 100 mL
EUGENOL (UNII: 3T8H1794QW)	0.00214 mL  in 100 mL
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)	0.0201 mL  in 100 mL
BENZYL CINNAMATE (UNII: V67O3RO97U)	0.004 mL  in 100 mL
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)	2.0097 mL  in 100 mL
MINERAL OIL (UNII: T5L8T28FGP)	37.332 mL  in 100 mL
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)	10.72 mL  in 100 mL
STYRENE/ISOPRENE COPOLYMER (28:72; 210000 MW) (UNII: H58HX2GWJ5)	4.148 mL  in 100 mL
ALMOND OIL (UNII: 66YXD4DKO9)	2 mL  in 100 mL
COCONUT OIL (UNII: Q9L0O73W7L)	2 mL  in 100 mL
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)	1 mL  in 100 mL
STANNIC OXIDE (UNII: KM7N50LOS6)	0.8468 mL  in 100 mL
FERRIC OXIDE RED (UNII: 1K09F3G675)	0.7076 mL  in 100 mL
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)	0.006 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84222-004-01	200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/28/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/28/2024

Labeler - Foshan Miwei Cosmetics Co., Ltd. (554530932)