BEACH BUM 30SPF SUNSCREEN 3FL OZ- beach bum 30 sport sunscreen 3fl oz lotion

BEACH BUM 30SPF SUNSCREEN 3FL OZ by

Drug Labeling and Warnings

BEACH BUM 30SPF SUNSCREEN 3FL OZ by is a Otc medication manufactured, distributed, or labeled by TSM BRANDS LLC, TSM BRANDS KIMYA SANAYI VE DIS TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Avobenzone 3.0%

Homosalate 8.0%

Octisalate 4.5%

Octocrylene 6.0%

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.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

When using this product, keep out of eyes. Rinse with water to remove.

STOP USE

Stop use and as a doctor if rash occurs

ASK A DOCTOR

Stop use and ask a doctor if rash occurs.

KEEP OUT OF REACH

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

INACTIVE INGREDIENTS

water, polyester-7, neopentyl glycol diheptanoate, glycerin, styrene/acrylates copolymer, alimunim starch octenylsuccinate, silica, pheoxyethanol, isododecane, arachidyl alcohol, beeswax, ethylhexyglycerin, acrylates/C10-30 akyl acrylate crosspolymer, behenyl alcohol, tocopherol (vitamin E), arachidyl glucoside, glyceryl stearate, PEK-100 stearate, potassium hydroxide, disodium EDTA, sodium ascorbyl phosphate, fragrance.

OTHER INFORMATION

Protect the product in this container from excessive heat and direct sun.

May stain or damage some fabrics, materials or surfaces.

WARNINGS

For external use only.

DIRECTIONS

Apply liberally 15 minutes before sun exposure.

Reapply:

-After 80 minutes of swimming or sweating.

-Immediately after towel drying.

-At least every 2 hours.

-Children under 6 months of age: Ask a doctor.

-Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10am - 2 pm

Wear long-sleeved shirts, pants, hats and sunglasses.

Directions

Apply liberally 15 minutes before sun exposure.

Reapply:

-After 80 minutes of swimming or sweating.

-Immediately after towel drying.

-At least every 2 hours.

-Children under 6 months of age: Ask a doctor.

-Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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 10am - 2 pm

Wear long-sleeved shirts, pants, hats and sunglasses.

LABELS

FRONT LABEL

BACK LABEL

INGREDIENTS AND APPEARANCE

BEACH BUM 30SPF SUNSCREEN 3FL OZ 
beach bum 30 sport sunscreen 3fl oz lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76567-9876
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.67 g  in 89 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.005 g  in 89 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5.34 g  in 89 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.12 g  in 89 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	2.67 mL  in 89 mL
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)	0.445 mL  in 89 mL
EDTA (UNII: 9G34HU7RV0)	0.089 mL  in 89 mL
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)	1.246 mL  in 89 mL
BEHENYL ALCOHOL (UNII: 9G1OE216XY)	0.356 mL  in 89 mL
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)	0.089 mL  in 89 mL
TOCOPHEROL (UNII: R0ZB2556P8)	0.089 mL  in 89 mL
BEESWAX (UNII: 2ZA36H0S2V)	1.78 mL  in 89 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.0445 mL  in 89 mL
ISODODECANE (UNII: A8289P68Y2)	0.089 mL  in 89 mL
HYDRATED SILICA (UNII: Y6O7T4G8P9)	0.001 mL  in 89 mL
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)	0.089 mL  in 89 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T)	0.4 mL  in 89 mL
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S AT 0.5%) (UNII: YY2HMJ9NZF)	0.1335 mL  in 89 mL
AQUA (UNII: 059QF0KO0R)	58.177 mL  in 89 mL
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)	3 mL  in 89 mL
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)	0.01 mL  in 89 mL
FRAGRANCE 13576 (UNII: 5EM498GW35)	0.445 mL  in 89 mL
POLYESTER-7 (UNII: 0841698D2F)	0.2225 mL  in 89 mL
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)	0.2225 mL  in 89 mL
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)	0.178 mL  in 89 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76567-9876-2	89 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/01/2025

Labeler - TSM BRANDS LLC (079777521)

Establishment
Name	Address	ID/FEI	Business Operations
TSM BRANDS KIMYA SANAYI VE DIS TICARET ANONIM SIRKETI		533120570	manufacture(76567-9876)