BOGEY BLOCKER SPF 30- homosalate, octisalate, octocrylene, titanium dioxide, zinc oxide lotion
Bogey Blocker LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Bogey Blocker (as PLD) - Bogey Blocker SPF 30 (83386-101)

ACTIVE INGREDIENTS

Homosalate 5%

Octisalate 3%
Octocrylene 5%

Titanium Dioxide 1%
Zinc Oxide 2%

PURPOSE

SUNSCREEN

USES

Helps prevent sunburn – If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

WARNINGS

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 use and ask a doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Apply liberally 15 mins before sun exposure – Reapply after 40 minutes of sweating or at least every 2 hours. Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use
sunscreen with Broad Spectrum SPF of 15 or higher.

INACTIVE INGREDIENTS

Water, Caprylic/Capric Triglycerides, VP/Eicosene Copolymer, Cetearyl Alcohol, Glyceryl Stearate SE, Polysorbate 60, Cyclopentasiloxane, Cyclotetrasiloxane, Sorbitan Stearate, Zea Mays Starch, Phenoxyethanol, Retinyl Palmitate, Tocopheryl
Acetate Antioxidant, Honey Extract, Aloe Barbadensis (Aloe Vera) Leaf Juice, Hydrogenated Vegetable Oil, Fragrance

01b LBL_Boogey Blocker SPF-30_118mL

BOGEY BLOCKER SPF 30
homosalate, octisalate, octocrylene, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83386-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	3 g in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1 g in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2 g in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	5 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STARCH, CORN (UNII: O8232NY3SJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 4 (UNII: CZ227117JE)
HONEY (UNII: Y9H1V576FH)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYDROGENATED PALM OIL (UNII: 257THB963H)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83386-101-14	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/10/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M020	04/10/2023

Labeler - Bogey Blocker LLC (123504643)