SUNSCREEN AND AMPHIBIOUS BULL FROG- spf 50 lotion

Sunscreen and Amphibious by

Drug Labeling and Warnings

Sunscreen and Amphibious by is a Otc medication manufactured, distributed, or labeled by Bullfrog Brands, LLC, ARG Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Avobenzone 3.0%, Octocrylene 10%, Homosalate 15%, Octisalate 5%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures, 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 medial help or contact a poison control center right away

FLAMMABLE:

do not use near heat, flame or while smoking

avoid long term storage above 104°F (40°C)

do not puncture or incinerate

contents under pressure

do not store at temperatures above 120°F (49°C).

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.

ASK DOCTOR

Stop use and ask a doctor if  rash occurs.

KEEP OUT OF REACH OF CHILDREN

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

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

Other information

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

Inactive ingredients

Acrylates/Copolymer, Acrylates/C10-30 Alkyl acrylate crosspolymer, carbomer, diisoproyl adipate, dimethyl capramide, disodium EDTA,ethylhexylglycerin, fragrance, hydroxypropyl methylcellulose, macrocystis pyrifera extract, phenoxyethanol, polyster-8, polyisobutene, propylene glycol, silica, sorbitan oleate, Vitamin E, triethanolamine, water

Questions or Comments?

www.bullfrogsunscreen.com or call toll-free 1-800-990-FROG

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

SUNSCREEN AND AMPHIBIOUS  BULL FROG
spf 50 lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77714-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)
TROLAMINE (UNII: 9O3K93S3TK)
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)
MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77714-004-15	148 g in 1 BOTTLE; Type 0: Not a Combination Product	01/19/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/19/2022

Labeler - Bullfrog Brands, LLC (117426500)

Establishment
Name	Address	ID/FEI	Business Operations
ARG Laboratories		117433599	manufacture(77714-004)